Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate · Capsule, Extended Release · Oral
Current shortage
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 0185-0842-01) – Available (Sandoz Inc., updated Sep 18, 2026)
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 0185-2098-01) – Available (Sandoz Inc., updated Sep 18, 2026)
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 0185-0853-01) – Available (Sandoz Inc., updated Sep 18, 2026)
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 0185-2099-01) – Available (Sandoz Inc., updated Sep 18, 2026)
Uses
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1) Limitations of Use The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. ( 5.5 , 8.4 ) 1.1 Attention Deficit Hyperactivity Disorder Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. Limitations of Use The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5) , Use is Specific Populations (8.4) ] .
Dosage and administration
Pediatric patients (ages 6 to 17): 10 mg once daily in the morning. Maximum dose for children 6 to 12 years of age is 30 mg once daily. ( 2.2 , 2.3 , 2.4 ) Adults: 20 mg once daily in the morning. ( 2.5 ) Pediatric patients (ages 6 to 17) with severe renal impairment: 5 mg once daily in the morning. Maximum dose for children 6 to 12 years of age with severe renal impairment is 20 mg once daily. ( 2.6 , 8.6 ) Adults with severe renal impairment: 15 mg once daily in the morning. ( 2.6 , 8.6 ) Patients with ESRD: Not recommended. ( 2.6 , 8.6 ) 2.1 Pretreatment Screening Prior to treating patients with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2) ]. the family history and clinically evaluate patients for motor or verbal tics or Tourette's syndrome before initiating dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules [see Warnings and Precautions (5.9) ] 2.2 General Administration Information Individualize the dosage according to the therapeutic needs and response of the patient. Administer dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules at the lowest effective dosage. Based on bioequivalence data, patients taking divided doses of immediate-release dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, (for example, twice daily), may be switched to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules at the same total daily dose taken once daily. Titrate at weekly intervals to appropriate efficacy and tolerability as indicated. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules may be taken whole, or the capsule may be opened and the entire contents sprinkled on applesauce. If the patient is using the sprinkle administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules may be taken orally with or without food. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules should be given upon awakening. Afternoon doses should be avoided because of the potential for insomnia. 2.3 Recommended Dosage in Pediatric Patients 6 to 12 Years In pediatric patients 6 to 12 years of age with ADHD and are either starting treatment for the first time or switching from another medication, start with 10 mg once daily in the morning; daily dosage may be adjusted in increments of 5 mg or 10 mg at weekly intervals. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with 5 mg once daily in the morning. The maximum recommended dose for children 6 to 12 years of age is 30 mg/day; doses greater than 30 mg/day have not been studied in children. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules has not been studied in children under 6 years of age. 2.4 Recommended Dosage in Pediatric Patients 13 to 17 Years The recommended starting dose for pediatric patients 13 to 17 years of age with ADHD and are either starting treatment for the first time or switching from another medication is 10 mg/day. The dose may be increased to 20 mg/day after one week if ADHD symptoms are not adequately controlled. 2.5 Recommended Dosage in Adults In adults with ADHD who are either starting treatment for the first time or switching from another medication, the recommended dose is 20 mg/day. 2.6 Dosage in Patients with Renal Impairment In adult patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73m 2 ), the recommended dose is 15 mg once daily in the morning. In pediatric patients (6 to 17 years of age) with severe renal impairment, the recommended dose is 5 mg once daily. The maximum dose for children 6 to 12 years of age with severe renal impairment is 20 mg once daily. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules is not recommended in patients with end stage renal disease (ESRD) (GFR < 15 mL/min/1.73m 2 ) [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )]. 2.7 Dosage Modification Due to Drug Interactions Agents that alter urinary pH can impact excretion and alter blood levels of amphetamines. Acidifying agents (e.g., ascorbic acid) decrease blood levels; adjust dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules dosage based on clinical response [see Drug Interactions (7) ] .
Dosage forms and strengths
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 5 mg: Capsule with white opaque body and lime green cap (imprinted 5 mg on body and ELI-510 on cap with black ink). Capsules filled with orange pellets. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 10 mg: Capsule with blue body and blue cap (imprinted 10 mg on body and ELI-511 on cap with black ink). Capsule filled with orange pellets. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 15 mg: Capsule with white opaque body and green cap (imprinted 15 mg on body and ELI-512 on cap with black ink). Capsule filled with orange pellets. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 20 mg: Capsule with white opaque body and light pink cap (imprinted 20 mg on body and ELI-513 on cap with black ink). Capsule filled with orange pellets. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 25 mg: Capsule with pink body and pink cap (imprinted 25 mg on body and ELI-514 on cap with black ink). Capsule filled with orange pellets. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 30 mg: Capsule with white opaque body and dark pink cap (imprinted 30 mg on body and ELI-515 on cap with black ink). Capsule filled with orange pellets. Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg ( 3 )
Contraindications
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules administration is contraindicated in patients: known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions (6.2) ] taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions (5.8) and Drug Interactions (7.1) ] Known hypersensitivity or idiosyncrasy to amphetamine ( 4 ) During or within 14 days following the administration of monoamine oxidase inhibitors (MAOI) ( 4 , 7.1 )
Warnings and precautions
Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. ( 5.2 ) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse at appropriate intervals. ( 5.3 ) Psychiatric Adverse Reactions: Prior to initiating dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules. ( 5.4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted. ( 5.5 ) Seizures: May lower the convulsive threshold. Discontinue in the presence of seizures. ( 5.6 ) Peripheral Vasculopathy, including Raynaud's phenomenon: Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's Phenomenon: Careful observation for digital changes is necessary during dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy. ( 5.7 ) Serotonin Syndrome: Increased risk when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situations. If it occurs, discontinue dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules and initiate supportive treatment ( 4 , 5.8 , 10 ). Motor and Verbal Tics, and Worsening of Tourette's Syndrome: Before initiating dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, assess the family history and clinically evaluate patients for tics or Tourette's syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette's syndrome. Discontinue treatment if clinically appropriate. ( 5.9 ) 5.1 Abuse, Misuse, and Addiction Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules have a high potential for abuse and misuse. The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence (9.2) ] . Misuse and abuse of CNS stimulants, including dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in a safe place, preferably locked, and instruct patients to not give dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules to anyone else. Throughout dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 5.2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 5.3 Increased Blood Pressure and Heart Rate CNS stimulants may cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Monitor all dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules treated patients for hypertension and tachycardia. 5.4 Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disease CNS stimulants may induce a manic or mixed episode in patients.
Side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2, 9.3 )] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.5) ] Seizures [see Warnings and Precautions (5.6) ] Peripheral Vasculopathy, including Raynaud’s Phenomenon [see Warnings and Precautions (5.7) ] Serotonin Syndrome [see Warnings and Precautions (5.8) ] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions (5.9) ] Pediatric patients ages 6 to 12: Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, emotional lability, vomiting, nervousness, nausea, and fever. (6.1) Pediatric patients ages 13 to 17: Most common adverse reactions (≥5% and with a higher incidence than on placebo) were loss of appetite, insomnia, abdominal pain, weight loss, and nervousness. (6.1) Adults: Most common adverse reactions ≥5% and with a higher incidence than on placebo were dry mouth, loss of appetite, insomnia, headache, weight loss, nausea, anxiety, agitation, dizziness, tachycardia, diarrhea, asthenia, and urinary tract infections. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Elite Laboratories, Inc. at 1-888-852-6657 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The premarketing development program for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules included exposures in a total of 1,315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects). Of these, 635 patients (ages 6 to 12) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40). Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs. Adverse reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse reactions. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. Adverse Reactions Leading to Discontinuation of Treatment In two placebo-controlled studies of up to 5 weeks duration among children with ADHD, 2.4% (10/425) of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsule-treated patients discontinued due to adverse reactions (including three patients with loss of appetite, one of whom also reported insomnia) compared to 2.7% (7/259) receiving placebo. The most frequent adverse reactions leading to discontinuation of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in controlled and uncontrolled, multiple-dose clinical trials of children (N=595) were anorexia (loss of appetite) (2.9%), insomnia (1.5%), weight loss (1.2%), emotional lability (1%), and depression (0.7%). Over half of these patients were exposed to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules for 12 months or more. In a separate placebo-controlled 4-week study in adolescents with ADHD, five patients (2.1%) discontinued treatment due to adverse events among dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsule-treated patients (N=233) compared to none who received placebo (N=54). The most frequent adverse event leading to discontinuation and considered to be drug-related (i.e., leading to discontinuation in at least 1% of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsule-treated patients and at a rate at least twice that of placebo) was insomnia (1.3%, n=3). In one placebo-controlled 4 week study among adults with ADHD with doses 20 to 60 mg, 23 patients (12.0%) discontinued treatment due to adverse events among dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsule-treated patients (N=191) compared to one patient (1.6%) who received placebo (N=64).
Drug interactions
Alkalinizing agents (GI antacids and urinary): These agents increase blood levels of amphetamine. ( 2.7 , 7.1 ) Acidifying agents (GI and urinary): These agents reduce blood levels of amphetamine. ( 7.1 ) 7.1 Clinically Important Interactions with Amphetamines Table 4: Drugs Having Clinically Important Interactions with Amphetamines Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Intervention Do not administer dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules concomitantly or within 14 days after discontinuing MAOI [see Contraindications (4) ] . Serotonergic Drugs Clinical Impact The concomitant use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules and serotonergic drugs increases the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules and the concomitant serotonergic drug(s) [see Warnings and Precautions (5.8) ] . CYP2D6 Inhibitors Clinical Impact The concomitant use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules and CYP2D6 inhibitors may increase the exposure of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules compared to the use of the drug alone and increase the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules and the CYP2D6 inhibitor [see Warnings and Precautions (5.8) and Overdosage (10) ]. Alkalinizing Agents Clinical Impact Increase blood levels and potentiate the action of amphetamine. Intervention Co-administration of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules and gastrointestinal or urinary alkalinizing agents should be avoided. Acidifying Agents Clinical Impact Lower blood levels and efficacy of amphetamines. Intervention Increase dose based on clinical response. Tricyclic Antidepressants Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Intervention Monitor frequently and adjust or use alternative therapy based on clinical response. Proton Pump Inhibitors Clinical Impact Time to maximum concentration (T max ) of amphetamine is decreased compared to when administered alone. Intervention Monitor patients for changes in clinical effect and adjust therapy based on clinical response. 7.2 Interference with Laboratory Tests Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations. Allow for an adequate washout period between administration of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules and radioactive diagnostic agents used for dopamine transporter (DAT) visualization. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules can interfere with the test results of a radioactive diagnostic agent (ioflupane I-123) that is used for DAT visualization by binding and internalization of the DAT, which may result in lower DAT in the striatum. This may lead to false-positive diagnostic results.
Use in specific populations
Pregnancy: May cause fetal harm. ( 8.1 ) Lactation: Breastfeeding not recommended. ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermediciations/. Risk Summary Available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified a drug-associated risk of major birth defects and miscarriage ( see Data ). Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers taking amphetamines during pregnancy ( see Clinical Considerations ). No apparent effects on morphological development were observed in embryo-fetal development studies, with oral administration of amphetamine to rats and rabbits during organogenesis at doses 2 and 12 times, respectively, the maximum recommended human dose (MRHD) of 20 mg/day given to adolescents, on a mg/m 2 basis. However, in a pre- and post-natal development study, amphetamine (d- to l - ratio of 3:1) administered orally to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine. In addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine. Long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Amphetamines, such as dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, cause vasoconstriction and thereby may decrease placental perfusion. In addition, amphetamines can stimulate uterine contractions, increasing the risk of premature delivery. Infants born to mothers taking amphetamines during pregnancy have an increased risk of premature delivery and low birth weight. Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness. Data Animal Data Amphetamine (d- to l - enantiomer ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (MRHD) of 20 mg/day given to adolescents, on a mg/m 2 basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 10 times the MRHD given to adolescents on a mg/m 2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity. A study was conducted in which pregnant rats received daily oral doses of amphetamine (d- to l- enantiomer ratio of 3:1) of 2, 6, and 10 mg/kg from gestation Day 6 to lactation Day 20. These doses are approximately 0.8, 2, and 4 times the MRHD of 20 mg/day given to adolescents, on a mg/m 2 basis. All doses caused hyperactivity and decreased weight gain in the dams. A decrease in pup survival was seen at all doses. A decrease in pup body weight was seen at 6 and 10 mg/kg which correlated with delays in developmental landmarks, such as preputial separation and vaginal opening. Increased pup locomotor activity was seen at 10 mg/kg on Day 22 postpartum but not at 5 weeks postweaning. When pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decreased in the group whose mothers had been given 10 mg/kg. A number of studies from the literature in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d, l-), at doses similar to those used clinically can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function. 8.2 Lactation Risk Summary Based on limited case reports in published literature, amphetamine (d- or d, l-) is present in human milk, at relative infant doses of 2 to 13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9 and 7.5. There are no reports of adverse effects on the breastfed infant. Long-term neurodevelopmental effects on infants from amphetamine exposure are unknown. It is possible that large dosages of amphetamine might interfere with milk production, especially in women whose lactation is not well established. Because of the potential for serious adverse reactions in nursing infants, advise patients that breastfeeding is not recommended during treatment with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules.
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermediciations/. Risk Summary Available data from published epidemiologic studies and postmarketing reports on use of prescription amphetamine in pregnant women have not identified a drug-associated risk of major birth defects and miscarriage ( see Data ). Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers taking amphetamines during pregnancy ( see Clinical Considerations ). No apparent effects on morphological development were observed in embryo-fetal development studies, with oral administration of amphetamine to rats and rabbits during organogenesis at doses 2 and 12 times, respectively, the maximum recommended human dose (MRHD) of 20 mg/day given to adolescents, on a mg/m 2 basis. However, in a pre- and post-natal development study, amphetamine (d- to l - ratio of 3:1) administered orally to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine. In addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine. Long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Amphetamines, such as dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, cause vasoconstriction and thereby may decrease placental perfusion. In addition, amphetamines can stimulate uterine contractions, increasing the risk of premature delivery. Infants born to mothers taking amphetamines during pregnancy have an increased risk of premature delivery and low birth weight. Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness. Data Animal Data Amphetamine (d- to l - enantiomer ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 2 and 12 times, respectively, the maximum recommended human dose (MRHD) of 20 mg/day given to adolescents, on a mg/m 2 basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 10 times the MRHD given to adolescents on a mg/m 2 basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity. A study was conducted in which pregnant rats received daily oral doses of amphetamine (d- to l- enantiomer ratio of 3:1) of 2, 6, and 10 mg/kg from gestation Day 6 to lactation Day 20. These doses are approximately 0.8, 2, and 4 times the MRHD of 20 mg/day given to adolescents, on a mg/m 2 basis. All doses caused hyperactivity and decreased weight gain in the dams. A decrease in pup survival was seen at all doses. A decrease in pup body weight was seen at 6 and 10 mg/kg which correlated with delays in developmental landmarks, such as preputial separation and vaginal opening. Increased pup locomotor activity was seen at 10 mg/kg on Day 22 postpartum but not at 5 weeks postweaning. When pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decreased in the group whose mothers had been given 10 mg/kg. A number of studies from the literature in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d, l-), at doses similar to those used clinically can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules have not been established in pediatric patients less than 6 years of age. The safety and effectiveness of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules have been established in pediatric patients with ADHD 6 years of age and older. In studies evaluating extended-release amphetamine products, patients 4 to <6 years of age had higher systemic amphetamine exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss. Long-Term Growth Suppression Growth should be monitored during treatment with stimulants, including dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, and pediatric patients aged 6 to 17 years who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.5) ]. Juvenile Animal Toxicity Data Juvenile rats treated with mixed amphetamine salts early in the postnatal period through sexual maturation demonstrated transient changes in motor activity. Learning and memory was impaired at approximately 6 times the maximum recommended human dose (MRHD) given to children on a mg/m 2 basis. No recovery was seen following a drug-free period. A delay in sexual maturation was observed at a dose approximately 6 times the MRHD given to children on a mg/m 2 basis, although there was no effect on fertility. In a juvenile developmental study, rats received daily oral doses of amphetamine (d to l enantiomer ratio of 3:1) of 2, 6, or 20 mg/kg on Days 7 to 13 of age; from Day 14 to approximately Day 60 of age these doses were given b.i.d. for total daily doses of 4, 12, or 40 mg/kg. The latter doses are approximately 0.6, 2, and 6 times the MRHD of 30 mg/day, given to children on a mg/m 2 basis. Post dosing hyperactivity was seen at all doses; motor activity measured prior to the daily dose was decreased during the dosing period but the decreased motor activity was largely absent after an 18 day drug-free recovery period. Performance in the Morris water maze test for learning and memory was impaired at the 40 mg/kg dose, and sporadically at the lower doses, when measured prior to the daily dose during the treatment period; no recovery was seen after a 19 day drug-free period. A delay in the developmental milestones of vaginal opening and preputial separation was seen at 40 mg/kg but there was no effect on fertility.
Geriatric use
8.5 Geriatric Use Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules has not been studied in the geriatric population.
Overdosage
Clinical Effect of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects include tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules should be considered when treating patients with overdose. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
Description
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D, L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules contains two types of drug-containing beads (immediate-release and delayed release) which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (immediate-release) tablet formulation. Each Capsule contains: Capsule Strength 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine (D,L)- Aspartate Monohydrate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Dextroamphetamine Sulfate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Amphetamine Sulfate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg Total amphetamine base equivalence 3.1 mg 6.3 mg 9.4 mg 12.5 mg 15.6 mg 18.8 mg d-amphetamine base equivalence 2.4 mg 4.7 mg 7.1 mg 9.5 mg 11.9 mg 14.2 mg l-amphetamine base equivalence 0.75 mg 1.5 mg 2.3 mg 3.0 mg 3.8 mg 4.5 mg Inactive Ingredients and Colors The inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules include: ferric oxide red, ferric oxide yellow, gelatin capsules, hypromellose 2910/3 cP, 6 cP and 50 cP, methacrylic acid and ethyl acrylate copolymer, titanium dioxide, polyethylene glycol, polysorbate 80, sugar spheres, talc, and triethyl citrate. The 5 mg gelatin capsules contain gelatin, titanium dioxide, D&C yellow #10, FD&C blue #1 and FD&C yellow #6. The 10 mg gelatin capsules contain gelatin, FD&C blue #1, and FD&C red #40. The 15 mg gelatin capsules contain gelatin, titanium dioxide, FD&C blue #1, and FD&C yellow #6. The 20 mg gelatin capsules contain gelatin, titanium dioxide, and FD&C red #3. The 25 mg gelatin capsules contain gelatin, FD&C red #40, and FD&C yellow #6. The 30 mg gelatin capsules contain gelatin, titanium dioxide, D&C red #28, and FD&C red #40. The ink ingredients are common for all strengths: the capsule imprint black ink contains FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, propylene glycol, and shellac.
Mechanism of action
12.1 Mechanism of Action Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.
How supplied
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 5 mg: capsule with white opaque body and lime green cap (imprinted 5 mg on body and ELI-510 on cap with black ink). Capsules filled with orange pellets, bottles of 100, NDC 64850-510-01 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 10 mg: capsules with blue body and blue cap (imprinted 10 mg on body and ELI-511 on cap with black ink). Capsules filled with orange pellets, bottles of 100, NDC 64850-511-01 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 15 mg: capsule with white opaque body and green cap (imprinted 15 mg on body and ELI-512 on cap with black ink). Capsules filled with orange pellets, bottles of 100, NDC 64850-512-01 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 20 mg: capsule with white opaque body and light pink cap (imprinted 20 mg on body and ELI-513 on cap with black ink). Capsules filled with orange pellets, bottles of 100, NDC 64850-513-01 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 25 mg: capsules with pink body and pink cap (imprinted 25 mg on body and ELI-514 on cap with black ink). Capsules filled with orange pellets, bottles of 100, NDC 64850-514-01 Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules 30 mg: capsules with white opaque body and dark pink cap (imprinted 30 mg on body and ELI-515 on cap with black ink). Capsules filled with orange pellets, bottles of 100, NDC 64850-515-01 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at room temperature, 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Storage
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. Store at room temperature, 20 to 25°C (68 to 77°F). Excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide) Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) , Overdosage (10) ] . Advise patients to store dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in a safe place, preferably locked, and instruct patients to not give dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules to anyone else. Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2) ] . Increased Blood Pressure and Heart Rate Advise patients that dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules can cause elevations in blood pressure and heart rate [see Warnings and Precautions (5.3) ] . Psychiatric Adverse Reactions Prior to initiating treatment with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, adequately screen patients with comorbid depressive symptoms to determine if they are at risk for bipolar disorder. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and/or depression. Additionally, dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules therapy at usual doses may cause treatment-emergent psychotic or manic symptoms in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4) ] . Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, including Raynaud's Phenomenon] Instruct patients beginning treatment with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules about the risk of peripheral vasculopathy, including Raynaud's Phenomenon, and in associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.7)] . Serotonin Syndrome Caution patients about the risk of serotonin syndrome with concomitant use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see Contraindications (4) , Warnings and Precautions (5.8) and Drug Interactions (7.1) ] . Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome. Concomitant Medications Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see Drug Interactions (7.1) ] . Advise patient or caregiver of steps to take with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules when a laboratory imaging procedure is ordered [see Drug Interactions (7.2) ]. Growth Monitor growth in children during treatment with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.5) ] . Motor and Verbal Tics, and Worsening of Tourette's Syndrome Advise patients that motor and verbal tics and worsening of Tourette’s syndrome may occur during treatment with dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette’s syndrome occurs [see Warnings and Precautions (5.9) ].
Label text from the FDA structured product label by Elite Laboratories, Inc. (revised Jun 18, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dextroamphetamine Saccharate in 92 products
- Dextroamphetamine Sulfate in 92 products
- Amphetamine Sulfate in 92 products
- Amphetamine Aspartate Monohydrate in 86 products
- Amphetamine Dl-aspartate Monohydrate in 6 products
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate NDC products (92)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0228-3064 | Dextroamphetamine Saccharate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25 mg/1; Dextroamphetamine Sulfate 6.25… Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 0228-3063 | Dextroamphetamine Saccharate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75 mg/1; Dextroamphetamine Sulfate 3.75… Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 0228-3062 | Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25 mg/1; Dextroamphetamine Sulfate 1.25… Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 0228-3061 | Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 0228-3060 | Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1;… Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 0228-3059 | Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1;… Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 0115-1487 | Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1;… Capsule | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1486 | Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25 mg/1; Dextroamphetamine Sulfate 1.25… Capsule | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1491 | Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… Capsule | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1490 | Dextroamphetamine Saccharate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25 mg/1; Dextroamphetamine Sulfate 6.25… Capsule | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1489 | Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1;… Capsule | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 0115-1488 | Dextroamphetamine Saccharate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75 mg/1; Dextroamphetamine Sulfate 3.75… Capsule | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 43975-277 | Amphetamine Sulfate 1.25 mg/1; Amphetamine Dl-aspartate Monohydrate 1.25 mg/1; Dextroamphetamine Sulfate 1.25 mg/1;… Capsule, Extended Release | ANI Pharmaceuticals, Inc. | ANDA · DEA CII |
| 43975-278 | Amphetamine Sulfate 2.5 mg/1; Amphetamine Dl-aspartate Monohydrate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1;… Capsule, Extended Release | ANI Pharmaceuticals, Inc. | ANDA · DEA CII |
| 43975-279 | Amphetamine Sulfate 3.75 mg/1; Amphetamine Dl-aspartate Monohydrate 3.75 mg/1; Dextroamphetamine Sulfate 3.75 mg/1;… Capsule, Extended Release | ANI Pharmaceuticals, Inc. | ANDA · DEA CII |
| 43975-280 | Amphetamine Sulfate 5 mg/1; Amphetamine Dl-aspartate Monohydrate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1;… Capsule, Extended Release | ANI Pharmaceuticals, Inc. | ANDA · DEA CII |
| 43975-281 | Amphetamine Sulfate 6.25 mg/1; Amphetamine Dl-aspartate Monohydrate 6.25 mg/1; Dextroamphetamine Sulfate 6.25 mg/1;… Capsule, Extended Release | ANI Pharmaceuticals, Inc. | ANDA · DEA CII |
| 43975-282 | Amphetamine Sulfate 7.5 mg/1; Amphetamine Dl-aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… Capsule, Extended Release | ANI Pharmaceuticals, Inc. | ANDA · DEA CII |
| 63629-1978 | Amphetamine Sulfate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25 mg/1; Dextroamphetamine Sulfate 1.25 mg/1;… Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1973 | Amphetamine Sulfate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1;… Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1974 | Amphetamine Sulfate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75 mg/1; Dextroamphetamine Sulfate 3.75 mg/1;… Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1975 | Amphetamine Sulfate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1;… Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1976 | Amphetamine Sulfate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25 mg/1; Dextroamphetamine Sulfate 6.25 mg/1;… Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1977 | Amphetamine Sulfate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1380 | Amphetamine Sulfate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25 mg/1; Dextroamphetamine Sulfate 6.25 mg/1;… Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1249 | Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1;… Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2070 | Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1377 | Amphetamine Sulfate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25 mg/1; Dextroamphetamine Sulfate 1.25 mg/1;… Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1381 | Amphetamine Sulfate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1378 | Amphetamine Sulfate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1;… Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1379 | Amphetamine Sulfate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1;… Capsule, Extended Release | Bryant Ranch Prepack | ANDA · DEA CII |
| 35573-464 | Dextroamphetamine Saccharate 1.25 mg/1; Dextroamphetamine Sulfate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25… Capsule, Extended Release | Burel Pharmaceuticals, LLC | ANDA · DEA CII |
| 35573-465 | Dextroamphetamine Saccharate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1;… Capsule, Extended Release | Burel Pharmaceuticals, LLC | ANDA · DEA CII |
| 35573-466 | Dextroamphetamine Saccharate 3.75 mg/1; Dextroamphetamine Sulfate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75… Capsule, Extended Release | Burel Pharmaceuticals, LLC | ANDA · DEA CII |
| 35573-467 | Dextroamphetamine Saccharate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1;… Capsule, Extended Release | Burel Pharmaceuticals, LLC | ANDA · DEA CII |
| 35573-468 | Dextroamphetamine Saccharate 6.25 mg/1; Dextroamphetamine Sulfate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25… Capsule, Extended Release | Burel Pharmaceuticals, LLC | ANDA · DEA CII |
| 35573-469 | Dextroamphetamine Saccharate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1;… Capsule, Extended Release | Burel Pharmaceuticals, LLC | ANDA · DEA CII |
| 31722-186 | Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1;… Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-187 | Dextroamphetamine Saccharate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75 mg/1; Dextroamphetamine Sulfate 3.75… Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-188 | Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1;… Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-189 | Dextroamphetamine Saccharate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25 mg/1; Dextroamphetamine Sulfate 6.25… Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-185 | Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25 mg/1; Dextroamphetamine Sulfate 1.25… Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-195 | Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… Capsule, Extended Release | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 64850-510 | Dextroamphetamine Saccharate 1.25 mg/1; Dextroamphetamine Sulfate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25… Capsule, Extended Release | Elite Laboratories, Inc. | ANDA · DEA CII |
| 64850-511 | Dextroamphetamine Saccharate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1;… Capsule, Extended Release | Elite Laboratories, Inc. | ANDA · DEA CII |
| 64850-512 | Dextroamphetamine Saccharate 3.75 mg/1; Dextroamphetamine Sulfate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75… Capsule, Extended Release | Elite Laboratories, Inc. | ANDA · DEA CII |
| 64850-513 | Dextroamphetamine Saccharate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1;… Capsule, Extended Release | Elite Laboratories, Inc. | ANDA · DEA CII |
| 64850-514 | Dextroamphetamine Saccharate 6.25 mg/1; Dextroamphetamine Sulfate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25… Capsule, Extended Release | Elite Laboratories, Inc. | ANDA · DEA CII |
| 64850-515 | Dextroamphetamine Saccharate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1;… Capsule, Extended Release | Elite Laboratories, Inc. | ANDA · DEA CII |
| 51407-562 | Dextroamphetamine Sulfate 7.5 mg/1; Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1;… Capsule, Extended Release | Golden State Medical Supply, Inc. | ANDA · DEA CII |
| 51407-560 | Dextroamphetamine Sulfate 5 mg/1; Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1;… Capsule, Extended Release | Golden State Medical Supply, Inc. | ANDA · DEA CII |
| 51407-559 | Dextroamphetamine Sulfate 3.75 mg/1; Dextroamphetamine Saccharate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75… Capsule, Extended Release | Golden State Medical Supply, Inc. | ANDA · DEA CII |
| 51407-558 | Dextroamphetamine Sulfate 2.5 mg/1; Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1;… Capsule, Extended Release | Golden State Medical Supply, Inc. | ANDA · DEA CII |
| 51407-557 | Dextroamphetamine Sulfate 1.25 mg/1; Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25… Capsule, Extended Release | Golden State Medical Supply, Inc. | ANDA · DEA CII |
| 51407-561 | Amphetamine Sulfate 6.25 mg/1; Dextroamphetamine Sulfate 6.25 mg/1; Dextroamphetamine Saccharate 6.25 mg/1; Amphetamine… Capsule, Extended Release | Golden State Medical Supply, Inc. | ANDA · DEA CII |
| 70010-034 | Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-033 | Dextroamphetamine Saccharate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25 mg/1; Dextroamphetamine Sulfate 6.25… Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-032 | Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1;… Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-031 | Dextroamphetamine Saccharate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75 mg/1; Dextroamphetamine Sulfate 3.75… Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-030 | Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1;… Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-029 | Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25 mg/1; Dextroamphetamine Sulfate 1.25… Capsule, Extended Release | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 0527-0795 | Dextroamphetamine Sulfate 7.5 mg/1; Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1;… Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-0790 | Dextroamphetamine Sulfate 1.25 mg/1; Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25… Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-0791 | Dextroamphetamine Sulfate 2.5 mg/1; Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1;… Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-0792 | Dextroamphetamine Sulfate 3.75 mg/1; Dextroamphetamine Saccharate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75… Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-0794 | Dextroamphetamine Sulfate 6.25 mg/1; Dextroamphetamine Saccharate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25… Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 0527-0793 | Dextroamphetamine Sulfate 5 mg/1; Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1;… Capsule, Extended Release | Lannett Company, Inc. | ANDA · DEA CII |
| 42858-720 | Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1;… Capsule, Extended Release | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-721 | Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25 mg/1; Dextroamphetamine Sulfate 1.25… Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-610 | Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1;… Capsule, Extended Release | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-325 | Dextroamphetamine Saccharate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25 mg/1; Dextroamphetamine Sulfate 6.25… Capsule, Extended Release | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-215 | Dextroamphetamine Saccharate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75 mg/1; Dextroamphetamine Sulfate 3.75… Capsule, Extended Release | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-055 | Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25 mg/1; Dextroamphetamine Sulfate 1.25… Capsule, Extended Release | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-930 | Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… Capsule, Extended Release | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-727 | Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-722 | Dextroamphetamine Saccharate 1.875 mg/1; Amphetamine Aspartate Monohydrate 1.875 mg/1; Dextroamphetamine Sulfate 1.875… Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-723 | Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1;… Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-724 | Dextroamphetamine Saccharate 3.125 mg/1; Amphetamine Aspartate Monohydrate 3.125 mg/1; Dextroamphetamine Sulfate 3.125… Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-725 | Dextroamphetamine Saccharate 3.75 mg/1; Amphetamine Aspartate Monohydrate 3.75 mg/1; Dextroamphetamine Sulfate 3.75… Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-726 | Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1;… Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 0185-0842 | Dextroamphetamine Saccharate 2.5 mg/1; Amphetamine Aspartate Monohydrate 2.5 mg/1; Dextroamphetamine Sulfate 2.5 mg/1;… Tablet | Sandoz Inc | ANDA · DEA CII |
| 0185-0853 | Dextroamphetamine Saccharate 5 mg/1; Amphetamine Aspartate Monohydrate 5 mg/1; Dextroamphetamine Sulfate 5 mg/1;… Tablet | Sandoz Inc | ANDA · DEA CII |
| 0185-2098 | Dextroamphetamine Saccharate 1.25 mg/1; Amphetamine Aspartate Monohydrate 1.25 mg/1; Dextroamphetamine Sulfate 1.25… Tablet | Sandoz Inc | ANDA · DEA CII |
| 0185-2099 | Dextroamphetamine Saccharate 7.5 mg/1; Amphetamine Aspartate Monohydrate 7.5 mg/1; Dextroamphetamine Sulfate 7.5 mg/1;… Tablet | Sandoz Inc | ANDA · DEA CII |
| 57664-950 | Dextroamphetamine Saccharate 3.125 mg/1; Amphetamine Aspartate Monohydrate 3.125 mg/1; Dextroamphetamine Sulfate 3.125… Capsule, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 57664-951 | Dextroamphetamine Saccharate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25 mg/1; Dextroamphetamine Sulfate 6.25… Capsule, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 57664-952 | Dextroamphetamine Saccharate 9.375 mg/1; Amphetamine Aspartate Monohydrate 9.375 mg/1; Dextroamphetamine Sulfate 9.375… Capsule, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 57664-953 | Dextroamphetamine Saccharate 12.5 mg/1; Amphetamine Aspartate Monohydrate 12.5 mg/1; Dextroamphetamine Sulfate 12.5… Capsule, Extended Release | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 0480-3685 | Dextroamphetamine Saccharate 9.375 mg/1; Amphetamine Aspartate Monohydrate 9.375 mg/1; Dextroamphetamine Sulfate 9.375… Capsule, Extended Release | Teva Pharmaceuticals, Inc. | ANDA · DEA CII |
| 0480-3684 | Dextroamphetamine Saccharate 6.25 mg/1; Amphetamine Aspartate Monohydrate 6.25 mg/1; Dextroamphetamine Sulfate 6.25… Capsule, Extended Release | Teva Pharmaceuticals, Inc. | ANDA · DEA CII |
| 0480-3683 | Dextroamphetamine Saccharate 3.125 mg/1; Amphetamine Aspartate Monohydrate 3.125 mg/1; Dextroamphetamine Sulfate 3.125… Capsule, Extended Release | Teva Pharmaceuticals, Inc. | ANDA · DEA CII |
| 0480-3686 | Dextroamphetamine Saccharate 12.5 mg/1; Amphetamine Aspartate Monohydrate 12.5 mg/1; Dextroamphetamine Sulfate 12.5… Capsule, Extended Release | Teva Pharmaceuticals, Inc. | ANDA · DEA CII |
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate recalls
- D-0660-2026 Jul 8, 2026 · Class II · Ongoing
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules. - D-0669-2025 Oct 1, 2025 · Class III · Ongoing
Failed Impurities/Degradation Specifications: - D-0670-2025 Oct 1, 2025 · Class III · Ongoing
Failed Impurities/Degradation Specifications: - D-0671-2025 Oct 1, 2025 · Class III · Ongoing
Failed Impurities/Degradation Specifications: - D-0672-2025 Oct 1, 2025 · Class III · Ongoing
Failed Impurities/Degradation Specifications: - D-0673-2025 Oct 1, 2025 · Class III · Ongoing
Failed Impurities/Degradation Specifications: - D-0043-2021 Oct 28, 2020 · Class III · Terminated
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - D-0044-2021 Oct 28, 2020 · Class III · Terminated
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - D-0045-2021 Oct 28, 2020 · Class III · Terminated
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - D-0046-2021 Oct 28, 2020 · Class III · Terminated
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - D-0047-2021 Oct 28, 2020 · Class III · Terminated
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - D-0048-2021 Oct 28, 2020 · Class III · Terminated
Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months. - D-190-2013 Mar 13, 2013 · Class III · Terminated
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Frequently asked questions
What is Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate used for?
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. (1) Limitations of Use The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate,…
What are the side effects of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate?
The following adverse reactions are discussed in greater detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2, 9.3 )] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] Psychiatric… See the full label for the complete list.
Who makes Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate?
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate is listed by 14 labelers in the FDA NDC directory, including Actavis Pharma, Inc., Amneal Pharmaceuticals of New York LLC, ANI Pharmaceuticals, Inc., Bryant Ranch Prepack.
Has Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate been recalled?
The FDA enforcement database lists 13 recalls for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate, most recently D-0660-2026 (class ii): Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.