Oxycodone Hydrochloride
Oxycodone · Tablet · Oral
Uses
Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.2) ] , reserve opioid analgesics, including Oxycodone Hydrochloride Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxycodone Hydrochloride Oral Solution is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, overdose, and death, with opioids, which can occur at any dosage or duration, and persist over the course of therapy, reserve opioid analgesics, including Oxycodone Hydrochloride Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.2 )
Dosage and administration
Periodically reassess patients receiving Oxycodone Hydrochloride Oral Solution to evaluate the continued need for opioid analgesics to maintain pain control, for signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse ( 2.5 ) Oxycodone Hydrochloride Oral Solution should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Oxycodone Hydrochloride Oral Solution for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse and misuse. ( 2.1 , 5.2 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Oxycodone Hydrochloride Oral Solution. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.3 ) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with Oxycodone Hydrochloride Oral Solution, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose ( 2.2 , 5.2 , 5.3 , 5.4 ) Initiate dosing with a range of 5 to 15 mg every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient's response to their initial dose of Oxycodone Hydrochloride Oral Solution. ( 2.3 , 2.4 ) Do not rapidly reduce or abruptly discontinue Oxycodone Hydrochloride Oral Solution in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ( 2.5 , 5.15 ) 2.1 Important Dosage and Administration Instructions Oxycodone Hydrochloride Oral Solution is available in two concentrations: 5 mg per 5 mL (1 mg/mL), and 100 mg per 5 mL (20 mg/mL). Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is for use in only opioid-tolerant adult patients who have already been receiving opioid therapy. Use this strength only for patients who have already been titrated to a stable analgesic regimen using lower strengths of oxycodone hydrochloride and who can benefit from use of a smaller volume of oral solution. Patients considered to be opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Ensure accuracy when prescribing, dispensing, and administering Oxycodone Hydrochloride Oral Solution to avoid dosing errors due to confusion between mg and mL, and with other oxycodone hydrochloride solutions of different concentrations, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume. Instruct patients and caregivers on how to accurately measure and take or administer the correct dose of Oxycodone Hydrochloride Oral Solution. Strongly advise patients and caregivers to always use the enclosed graduated measuring cup when administering Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL and always use the enclosed graduated oral syringe when administering Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL) to ensure that the dose is measured and administered accurately. Instruct patients and caregivers to never use household teaspoons or tablespoons to measure Oxycodone Hydrochloride Oral Solution. Oxycodone Hydrocodone Oral Solution should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5) ]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Oxycodone Hydrochloride Oral Solution for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.2) ]. Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Oxycodone Hydrochloride Oral Solution.
Dosage forms and strengths
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL) Strength Oral Solution: Each 5 mL of red Oxycodone Hydrochloride Oral Solution, USP contains oxycodone hydrochloride 5 mg. 100 mg per 5 mL (20 mg per mL) Strength Oral Solution: Each 5 mL of yellow Oxycodone Hydrochloride Oral Solution, USP contains oxycodone hydrochloride 100 mg. Oral Solution 5 mg per 5 mL (1 mg/mL) 100 mg per 5 mL (20 mg/mL) ( 3 )
Contraindications
Oxycodone Hydrochloride Oral Solution is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3) ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.9) ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.13) ] Hypersensitivity to oxycodone (e.g., angioedema) [see Adverse Reactions (6) ] Significant respiratory depression ( 4 ) Acute or severe bronchial asthma in an unmonitored setting in absence of resuscitative equipment. ( 4 ) Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) Hypersensitivity to oxycodone. ( 4 )
Warnings and precautions
Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.8 ) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic or Debilitated Patients : Regularly evaluate, particularly during initiation and titration. ( 5.9 ) Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.10 ) Severe Hypotension : Regularly evaluate during dosage initiation and titration. Avoid use of Oxycodone Hydrochloride Oral Solution in patients with circulatory shock. ( 5.11 ) Risks of Use in Patients with Increased lntracranial Pressure, Brain Tumors, Head Injury or Impaired Consciousness : Monitor for sedation and respiratory depression. Avoid use of Oxycodone Hydrochloride Oral Solution in patients with impaired consciousness or coma. ( 5.12 ) 5.1 Risk of Accidental Overdose and Death due to Medication Errors Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with oxycodone hydrochloride solutions of different concentrations, when prescribing, dispensing, and administering Oxycodone Hydrochloride Oral Solution. Ensure that the dose is communicated clearly and dispensed accurately. Instruct patients and caregivers on how to measure and take or administer the correct dose of Oxycodone Hydrochloride Oral Solution and to use extreme caution when measuring the dose. Instruct patients and caregivers to always use the enclosed graduated measuring cup when administering Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL (1 mg/mL) and always use the enclosed graduated oral syringe when administering Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/ mL) to ensure the dose is measured and administered accurately. Instruct them to never use a teaspoon or a tablespoon to measure a dose because household teaspoons or tablespoon are not adequate measuring devices. 5.2 Addiction, Abuse, and Misuse Oxycodone Hydrochloride Oral Solution contains oxycodone, a Schedule II controlled substance. As an opioid, Oxycodone Hydrochloride Oral Solution exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9) ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Oxycodone Hydrochloride Oral Solution. Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see Adverse Reactions (6) ] . Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing Oxycodone Hydrochloride Oral Solution, and reassess all patients receiving Oxycodone Hydrochloride Oral Solution for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Oxycodone Hydrochloride Oral Solution but use in such patients necessitates intensive counseling about the risks and proper use of Oxycodone Hydrochloride Oral Solution along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2) , Warnings and Precautions (5.3) ]. Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when prescribing or dispensing Oxycodone Hydrochloride Oral Solution. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on careful storage of the drug during the course of treatment and on the proper disposal of unused drug. Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 5.3 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents depending on the patient's clinical status [see Overdosage (10) ]. Carbon dioxide (C0 2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Oxycodone Hydrochloride Oral Solution, the risk is greatest during the initiation of therapy or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Oxycodone Hydrochloride Oral Solution are essential [see Dosage and Administration (2) ] . Over estimating the Oxycodone Hydrochloride Oral Solution dosage when converting patients from another opioid product can result in a fatal overdose with the first dose. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is for use in opioid-tolerant patients only.
Side effects
The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.2) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.4) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.5) ] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.8) ] Adrenal Insufficiency [see Warnings and Precautions (5.10) ] Severe Hypotension [ see Warnings and Precautions (5.11) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.13) ] Seizures [see Warnings and Precautions (5.14) ] Withdrawal [see Warnings and Precautions (5.15) ] The following adverse reactions associated with the use of oxycodone were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions associated with oxycodone use included: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock. The common adverse reactions seen on initiation of therapy with oxycodone are dose-related and are typical opioid-related adverse reactions. The most frequent adverse events include nausea, constipation, vomiting, headache, and pruritus. The frequency of these reactions depended on several factors, including clinical setting, the patient's level of opioid tolerance, and host factors specific to the individual. In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving another formulation of immediate-release oxycodone, the following adverse events were recorded in oxycodone treated patients with an incidence ≥ 3%. In descending order of frequency, they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. The other less frequently observed adverse reactions from opioid analgesics, including Oxycodone Hydrochloride Oral Solution included: Body as a Whole: abdominal pain, accidental injury, allergic reaction, back pain, chills and fever, fever, flu syndrome, infection, neck pain, pain, photosensitivity reaction, and sepsis. Cardiovascular: deep thrombophlebitis, heart failure, hemorrhage, hypotension, migraine, palpitation, and tachycardia. Digestive: anorexia, diarrhea, dyspepsia, dysphagia, gingivitis, glossitis, and nausea and vomiting. Hemic and Lymphatic: anemia and leukopenia. Metabolic and Nutritional: edema, gout, hyperglycemia, iron deficiency anemia and peripheral edema. Musculoskeletal: arthralgia, arthritis, bone pain, myalgia and pathological fracture. Nervous: agitation, anxiety, confusion, dry mouth, hypertonia, hypesthesia, nervousness, neuralgia, personality disorder, tremor, and vasodilation. Respiratory: bronchitis, cough increased, dyspnea, epistaxis, laryngismus, lung disorder, pharyngitis, rhinitis, and sinusitis. Skin and Appendages: herpes simplex, rash, sweating, and urticaria. Special Senses: amblyopia. Urogenital : urinary tract infection Serotonin syndrome: Cases of serotonin syndrome, a potentially life threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Oxycodone Hydrochloride Oral Solution. Androgen deficiency: Cases of androgen deficiency have occurred with use of opioids for an extended period of time [see Clinical Pharmacology (12.2) ]. Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings and Precautions (5.8) ]. Hypoglycemia : Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes). Opioid-induced esophageal dysfunction (OIED): Cases of OIED have been reported in patients taking opioids and may occur more frequently in patients taking higher doses of opioids, and/or in patients taking opioids longer term [see Warnings and Precautions (5.13) ] . Adverse Reactions from Observational Studies A prospective, observational cohort study estimated the risks of addiction, abuse, and misuse in patients initiating long-term use of Schedule II opioid analgesics between 2017 and 2021. Study participants included in one or more analyses had been enrolled in selected insurance plans or health systems for at least one year, were free of at least one outcome at baseline, completed a minimum number of follow-up assessments, and either: 1) filled multiple extended-release/long-acting opioid analgesic prescriptions during a 90-day period (n=978); or 2) filled any Schedule II opioid analgesic prescriptions covering at least 70 of 90 days (n=1,244). Those included also had no dispensing of the qualifying opioids in the previous 6 months. Over 12 months: approximately 1% to 6% of participants across the two cohorts newly met criteria for addiction, as assessed with two validated interview-based measures of moderate-to-severe opioid use disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, and approximately 9% and 22% of participants across the two cohorts newly met criteria for prescription opioid abuse and misuse [defined in Drug Abuse and Dependence (9.2)], respectively, as measured with a validated self-reported instrument.
Drug interactions
Table 1 includes clinically significant drug interactions with Oxycodone Hydrochloride Oral Solution. Table 1: Clinically Significant Drug Interactions with Oxycodone Hydrochloride Oral Solution Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of Oxycodone Hydrochloride Oral Solution and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Oxycodone Hydrochloride Oral Solution and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of Oxycodone Hydrochloride Oral Solution is achieved [see Warnings and Precautions (5.7) ]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see Clinical Pharmacology (12.3) ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oxycodone. Intervention: If concomitant use is necessary, consider dosage reduction of Oxycodone Hydrochloride Oral Solution until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the Oxycodone Hydrochloride Oral Solution dosage until stable drug effects are achieved. Evaluate for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin, azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir) CYP3A4 Inducers Clinical Impact: The concomitant use of Oxycodone Hydrochloride Oral Solution and CYP3A4 inducers can decrease the plasma concentration of oxycodone [see Clinical Pharmacology (12.3) ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oxycodone [see Warnings and Precautions (5.15) ] . After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see Clinical Pharmacology (12.3) ] , which could increase or prolong both the therapeutic effects and adverse reactions and may cause serious respiratory depression. Intervention: If concomitant use is necessary, consider increasing the Oxycodone Hydrochloride Oral Solution dosage until stable drug effects are achieved. Evaluate patients for signs of opioid withdrawal and sedation. If a CYP3A4 inducer is discontinued, consider Oxycodone Hydrochloride Oral Solution dosage reduction and evaluate patients at frequent intervals for signs of respiratory depression and sedation. Examples Rifampin, carbamazepine, phenytoin Benzodiazepines and other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider recommending or prescribing of an opioid overdose reversal agent [see Dosage and Administration (2.2) , Warnings and Precautions (5.2 , 5.3 , 5.4) ] . Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Intervention: If concomitant use is warranted, frequently reevaluate the patient, particularly during treatment initiation and dose adjustment. Discontinue Oxycodone Hydrochloride Oral Solution if serotonin syndrome is suspected. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.3) ] . Intervention: The use of Oxycodone Hydrochloride Oral Solution is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. Examples: phenelzine, tranylcypromine, linezolid Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics Clinical Impact: May reduce the analgesic effect of Oxycodone Hydrochloride Oral Solution and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Intervention: Because respiratory depression that may be greater than otherwise expected, decrease the dosage of Oxycodone Hydrochloride Oral Solution and/or the muscle relaxant as necessary.
Use in specific populations
Pregnancy: May cause fetal harm. ( 8.1 ) 8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5) ]. Available data with Oxycodone Hydrochloride Oral Solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity. In several published studies, treatment of pregnant rats with oxycodone at clinically relevant doses and below, resulted in neurobehavioral effects in offspring [see Data ]. Based on animal data, advise pregnant women of the potential risk to a fetus. The 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 Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.5) ]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Oxycodone Hydrochloride Oral Solution is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Oxycodone Hydrochloride Oral Solution, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of oxycodone hydrochloride administered during the period of organogenesis up to 16 mg/kg/day and up 25 mg/kg/day, respectively. These studies revealed no evidence of teratogenicity or embryo-fetal toxicity due to oxycodone. The highest doses tested in rats and rabbits were equivalent to approximately 2.6 and 8.1 times an adult human dose of 60 mg/day, respectively, on a mg/m 2 basis. In published studies, offspring of pregnant rats administered oxycodone during gestation have been reported to exhibit neurobehavioral effects including altered stress responses, increased anxiety-like behavior (2 mg/kg/day IV from Gestation Day 8 to 21 and Postnatal Day 1, 3, and 5; 0.3-times an adult human dose of 60 mg/day, on a mg/m2 basis) and altered learning and memory (15 mg/kg/day orally from breeding through parturition; 2.4 times an adult human dose of 60 mg/day, on a mg/m 2 basis). 8.2 Lactation Risk Summary Available data from lactation studies indicate that oxycodone is present in breastmilk and that doses of less than 60 mg/day of the immediate-release formulation are unlikely to result in clinically relevant exposures in breastfed infants. A pharmacokinetics study utilizing opportunistic sampling of 76 lactating women receiving oxycodone immediate-release products for postpartum pain management showed that oxycodone concentrates in breastmilk with an average milk to plasma ratio of 3.2. The relative infant dose was low, approximately 1.3% of a weight-adjusted maternal dose ( see Data ) . In the same study, among the 70 infants exposed to oxycodone in breastmilk, no adverse events were attributed to oxycodone. However, based on known adverse effects in adults, infants should be monitored for signs of excess sedation and respiratory depression ( see Clinical Considerations ) . There are no data on the effects of the oxycodone on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Oxycodone Hydrochloride Oral Solution and any potential adverse effects on the breastfed infant from Oxycodone Hydrochloride Oral Solution or from the underlying maternal condition. Clinical Considerations Monitor infants exposed to Oxycodone Hydrochloride Oral Solution through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Data Oxycodone concentration data from 76 lactating women receiving immediate-release oxycodone products for postpartum pain management, and 28 infants exposed to oxycodone in breastmilk showed that following a median (range) dose of oxycodone in mothers of 9.2 (5-10) mg/dose or 33.0 (5.4-59.3) mg/day, oxycodone concentrated in breastmilk with a median (range) milk to plasma ratio of 3.2 (1.2-5.3).
Pregnancy
8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.5) ]. Available data with Oxycodone Hydrochloride Oral Solution are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Animal reproduction studies with oral administrations of oxycodone hydrochloride in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity. In several published studies, treatment of pregnant rats with oxycodone at clinically relevant doses and below, resulted in neurobehavioral effects in offspring [see Data ]. Based on animal data, advise pregnant women of the potential risk to a fetus. The 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 Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.5) ]. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Oxycodone Hydrochloride Oral Solution is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including Oxycodone Hydrochloride Oral Solution, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of oxycodone hydrochloride administered during the period of organogenesis up to 16 mg/kg/day and up 25 mg/kg/day, respectively. These studies revealed no evidence of teratogenicity or embryo-fetal toxicity due to oxycodone. The highest doses tested in rats and rabbits were equivalent to approximately 2.6 and 8.1 times an adult human dose of 60 mg/day, respectively, on a mg/m 2 basis. In published studies, offspring of pregnant rats administered oxycodone during gestation have been reported to exhibit neurobehavioral effects including altered stress responses, increased anxiety-like behavior (2 mg/kg/day IV from Gestation Day 8 to 21 and Postnatal Day 1, 3, and 5; 0.3-times an adult human dose of 60 mg/day, on a mg/m2 basis) and altered learning and memory (15 mg/kg/day orally from breeding through parturition; 2.4 times an adult human dose of 60 mg/day, on a mg/m 2 basis).
Pediatric use
8.4 Pediatric Use The safety and effectiveness of Oxycodone Hydrochloride Oral Solution have not been established in pediatric patients. The safety and pharmacokinetics of a single-dose of an Oxycodone Hydrochloride Oral Solution were evaluated in an open-label clinical trial in 89 pediatric patients 2 years to less than 17 years of age with postoperative pain. However, definitive conclusions were not possible because of insufficient information.
Geriatric use
8.5 Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone. In general, use caution when selecting a dose for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of Oxycodone Hydrochloride Oral Solution slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see Warnings and Precautions (5.9) ]. Oxycodone is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function.
Overdosage
Clinical Presentation Acute overdose with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2) ]. Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication. Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone in Oxycodone Hydrochloride Oral Solution, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed by the product's prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the opioid overdose reversal agent will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the reversal agent administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the reversal agent should be initiated with care and by titration with smaller than usual doses of the reversal agent.
Description
11. DESCRIPTION Oxycodone Hydrochloride Oral Solution is an agonist, available as a red solution 5 mg/5 mL (1 mg/mL) and a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18 H 21 NO 4 ∙HCl, and it has the following chemical structure: Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, 5 mg per 5 mL (l mg/mL) include: citric acid anhydrous, FD&C Red #40, natural/artificial berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, sorbitol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) include: citric acid anhydrous, D&C Yellow #10, natural/artificial berry flavor, purified water, sodium citrate dihydrate, sodium benzoate, saccharin sodium, sorbitol. Chemical Structure
Mechanism of action
12.1 Mechanism of Action Oxycodone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
How supplied
Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL (1 mg/mL), is a red solution, supplied as: NDC# 64950-354-10: Bottle of 100 mL supplied with a calibrated measuring cup NDC# 64950-354-50: Bottle of 500 mL supplied with a calibrated measuring cup NDC# 64950-354-05: 5 mL unit dose cup NDC# 64950-354-45: Case contains 40 unit dose cups of 5 mL (NDC 64950-354-05), packaged in 4 trays of 10 unit dose cups each NDC# 64950-354-55: Case contains 50 unit dose cups of 5 mL (NDC 64950-354-05), packaged in 5 trays of 10 unit dose cups each Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg per mL), is a yellow solution, supplied as: NDC# 64950-353-03: Bottle of 30 mL supplied with a calibrated oral syringe Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° - 30°C (59° - 86°F). PROTECT from MOISTURE and LIGHT. Store Oxycodone Hydrochloride Oral Solution securely and dispose of properly .
Storage
Store at Controlled Room Temperature, 25°C (77°F); excursions are permitted to 15° - 30°C (59° - 86°F). PROTECT from MOISTURE and LIGHT. Store Oxycodone Hydrochloride Oral Solution securely and dispose of properly .
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Storage and Disposal: Because of the risks associated with accidental ingestion, misuse, and abuse, advise patients to store Oxycodone Hydrochloride Oral Solution securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Inform patients that leaving Oxycodone Hydrochloride Oral Solution unsecured can pose a deadly risk to others in the home ( see Warnings and Precautions (5.2 , 5.3) , Drug Abuse and Dependence (9.2) ]. Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused Oxycodone Hydrochloride Oral Solution should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available. Inform patients that they can visit www.fda.gov/drugdisposal for a complete list of medicines recommended for disposal by flushing, as well as additional information on disposal of unused medicines. Medication Errors Instruct patients and caregivers how to measure and take or administer the correct dose of Oxycodone Hydrochloride Oral Solution and to always use the enclosed graduated measuring cup when administering Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL (1 mg/mL) and to always use the enclosed graduated oral syringe when administering Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) to correctly measure the prescribed amount of medication [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) ]. Advise patients and caregivers that Oxycodone Hydrochloride Oral Solution, is available in two concentrations: 5 mg/5 mL and 100 mg/5 mL. Inform patients and caregivers about which concentration they have been prescribed and provide detailed instruction on how to measure and take or administer the correct dose of Oxycodone Hydrochloride Oral Solution, and to always use the enclosed measuring device when administering Oxycodone Hydrochloride Oral Solution, to ensure that the dose is measured and administered accurately. If the prescribed concentration is changed, instruct patients and caregivers on how to correctly measure the new dose to avoid errors which could result in accidental overdose and death. Addiction, Abuse, and Misuse Inform patients that the use of Oxycodone Hydrochloride Oral Solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.2) ] . Instruct patients not to share Oxycodone Hydrochloride Oral Solution with others and to take steps to protect Oxycodone Hydrochloride Oral Solution from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Oxycodone Hydrochloride Oral Solution or when the dosage is increased, and that it can occur even at recommended dosages. Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions (5.3) ]. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see Warnings and Precautions (5.3) ] . Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if Oxycodone Hydrochloride Oral Solution is used with benzodiazepines or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids), and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions (5.4) , Drug Interactions (7) ]. Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose. Discuss with the patient the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program) [see Dosage and Administration (2.2) , Warnings and Precautions (5.4) ] . Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to patients and patients and caregivers that effects of opioid overdose reversal agents like naloxone and nalmefene are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if an opioid overdose reversal agent is administered [see Overdosage (10) ]. Advise patients and caregivers: how to treat with the overdose reversal agent in the event of an opioid overdose to tell family and friends about the opioid reversal agent, and to keep it in a place where family and friends can access it in an emergency to read the Patient Information (or other educational material) that will come with their opioid overdose reversal agent. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do. Hyperalgesia and Allodynia Inform patients and caregivers not to increase opioid dosage without first consulting a clinician.
Label text from the FDA structured product label by Genus Lifesciences Inc. (revised Apr 16, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Oxycodone Hydrochloride in 131 products
Oxycodone Hydrochloride NDC products (131)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 47781-265 | Oxycodone Hydrochloride 30 mg/1 Tablet | Alvogen, Inc. | ANDA · DEA CII |
| 47781-264 | Oxycodone Hydrochloride 15 mg/1 Tablet | Alvogen, Inc. | ANDA · DEA CII |
| 47781-263 | Oxycodone Hydrochloride 5 mg/1 Tablet | Alvogen, Inc. | ANDA · DEA CII |
| 68084-983 | Oxycodone Hydrochloride 30 mg/1 Tablet | American Health Packaging | ANDA · DEA CII |
| 68084-975 | Oxycodone Hydrochloride 15 mg/1 Tablet | American Health Packaging | ANDA · DEA CII |
| 60687-406 | Oxycodone Hydrochloride 5 mg/5mL Solution | American Health Packaging | ANDA · DEA CII |
| 68084-968 | Oxycodone Hydrochloride 10 mg/1 Tablet | American Health Packaging | ANDA · DEA CII |
| 68084-354 | Oxycodone Hydrochloride 5 mg/1 Tablet | American Health Packaging | ANDA · DEA CII |
| 65162-047 | Oxycodone Hydrochloride 5 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA · DEA CII |
| 65162-051 | Oxycodone Hydrochloride 30 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA · DEA CII |
| 65162-050 | Oxycodone Hydrochloride 20 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA · DEA CII |
| 65162-049 | Oxycodone Hydrochloride 15 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA · DEA CII |
| 65162-048 | Oxycodone Hydrochloride 10 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA · DEA CII |
| 62559-167 | Oxycodone Hydrochloride 5 mg/1 Capsule | ANI Pharmaceuticals, Inc. | ANDA · DEA CII |
| 62559-151 | Oxycodone Hydrochloride 5 mg/5mL Solution | ANI Pharmaceuticals, Inc. | ANDA · DEA CII |
| 43602-190 | Oxycodone Hydrochloride 5 mg/5mL Solution | Ascent Pharmaceuticals Inc | ANDA · DEA CII |
| 43602-198 | Oxycodone Hydrochloride 100 mg/5mL Solution | Ascent Pharmaceuticals Inc | ANDA · DEA CII |
| 76420-897 | Oxycodone Hydrochloride 5 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-761 | Oxycodone Hydrochloride 20 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-362 | Oxycodone Hydrochloride 5 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-363 | Oxycodone Hydrochloride 10 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-364 | Oxycodone Hydrochloride 15 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-365 | Oxycodone Hydrochloride 20 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-366 | Oxycodone Hydrochloride 30 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-757 | Oxycodone Hydrochloride 10 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-758 | Oxycodone Hydrochloride 15 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-762 | Oxycodone Hydrochloride 30 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-763 | Oxycodone Hydrochloride 5 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-764 | Oxycodone Hydrochloride 15 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-768 | Oxycodone Hydrochloride 30 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 13107-057 | Oxycodone Hydrochloride 30 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 13107-056 | Oxycodone Hydrochloride 15 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 13107-055 | Oxycodone Hydrochloride 5 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 72162-1749 | Oxycodone Hydrochloride 5 mg/5mL Solution | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1930 | Oxycodone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-8526 | Oxycodone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-8890 | Oxycodone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1174 | Oxycodone Hydrochloride 5 mg/5mL Solution | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2104 | Oxycodone Hydrochloride 5 mg/5mL Solution | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1361 | Oxycodone Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1335 | Oxycodone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1334 | Oxycodone Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2816 | Oxycodone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2126 | Oxycodone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1422 | Oxycodone Hydrochloride 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1421 | Oxycodone Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1414 | Oxycodone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1413 | Oxycodone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1812 | Oxycodone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1245 | Oxycodone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1080 | Oxycodone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1023 | Oxycodone Hydrochloride 20 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-0981 | Oxycodone Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-0677 | Oxycodone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1337 | Oxycodone Hydrochloride 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1336 | Oxycodone Hydrochloride 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1811 | Oxycodone Hydrochloride 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 31722-918 | Oxycodone Hydrochloride 30 mg/1 Tablet | Camber Pharmaceuticals Inc | ANDA · DEA CII |
| 31722-917 | Oxycodone Hydrochloride 15 mg/1 Tablet | Camber Pharmaceuticals Inc | ANDA · DEA CII |
| 31722-486 | Oxycodone Hydrochloride 20 mg/1 Tablet | Camber Pharmaceuticals Inc | ANDA · DEA CII |
| 31722-485 | Oxycodone Hydrochloride 10 mg/1 Tablet | Camber Pharmaceuticals Inc | ANDA · DEA CII |
| 31722-484 | Oxycodone Hydrochloride 5 mg/1 Tablet | Camber Pharmaceuticals Inc | ANDA · DEA CII |
| 72189-095 | Oxycodone Hydrochloride 5 mg/1 Tablet | DIRECT RX | ANDA · DEA CII |
| 72189-094 | Oxycodone Hydrochloride 10 mg/1 Tablet | DIRECT RX | ANDA · DEA CII |
| 42806-007 | Oxycodone Hydrochloride 15 mg/1 Tablet | Epic Pharma, LLC | ANDA · DEA CII |
| 42806-008 | Oxycodone Hydrochloride 30 mg/1 Tablet | Epic Pharma, LLC | ANDA · DEA CII |
| 42806-006 | Oxycodone Hydrochloride 10 mg/1 Tablet | Epic Pharma, LLC | ANDA · DEA CII |
| 42806-005 | Oxycodone Hydrochloride 5 mg/1 Tablet | Epic Pharma, LLC | ANDA · DEA CII |
| 42806-009 | Oxycodone Hydrochloride 20 mg/1 Tablet | Epic Pharma, LLC | ANDA · DEA CII |
| 71930-023 | Oxycodone Hydrochloride 20 mg/mL Solution | Eywa Pharma Inc | ANDA · DEA CII |
| 71930-022 | Oxycodone Hydrochloride 5 mg/5mL Solution | Eywa Pharma Inc | ANDA · DEA CII |
| 0054-0390 | Oxycodone Hydrochloride 5 mg/5mL Solution | Hikma Pharmceuticals USA Inc. | ANDA · DEA CII |
| 10702-171 | Oxycodone Hydrochloride 100 mg/5mL Solution | KVK-Tech, Inc. | ANDA · DEA CII |
| 10702-183 | Oxycodone Hydrochloride 5 mg/5mL Solution | KVK-Tech, Inc. | ANDA · DEA CII |
| 10702-023 | Oxycodone Hydrochloride 5 mg/1 Capsule | KVK-TECH, INC. | ANDA · DEA CII |
| 10702-057 | Oxycodone Hydrochloride 20 mg/1 Tablet | KVK-TECH,INC | ANDA · DEA CII |
| 10702-008 | Oxycodone Hydrochloride 15 mg/1 Tablet | KVK-TECH,INC | ANDA · DEA CII |
| 10702-009 | Oxycodone Hydrochloride 30 mg/1 Tablet | KVK-TECH,INC | ANDA · DEA CII |
| 10702-018 | Oxycodone Hydrochloride 5 mg/1 Tablet | KVK-TECH,INC | ANDA · DEA CII |
| 10702-056 | Oxycodone Hydrochloride 10 mg/1 Tablet | KVK-TECH,INC | ANDA · DEA CII |
| 43386-920 | Oxycodone Hydrochloride 20 mg/mL Solution | Lupin Pharmaceuticals, Inc. | ANDA · DEA CII |
| 43386-433 | Oxycodone Hydrochloride 10 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-434 | Oxycodone Hydrochloride 20 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-430 | Oxycodone Hydrochloride 15 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-431 | Oxycodone Hydrochloride 30 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-432 | Oxycodone Hydrochloride 5 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 0904-6966 | Oxycodone Hydrochloride 5 mg/1 Tablet | Major Pharmaceuticals | ANDA · DEA CII |
| 0904-6828 | Oxycodone Hydrochloride 5 mg/5mL Solution | MAJOR PHARMACEUTICALS | ANDA · DEA CII |
| 0904-6678 | Oxycodone Hydrochloride 5 mg/5mL Solution | MAJOR PHARMACEUTICALS | ANDA · DEA CII |
| 0904-7180 | Oxycodone Hydrochloride 15 mg/1 Tablet | Major Pharmaceuticals | ANDA · DEA CII |
| 40032-950 | Oxycodone Hydrochloride 5 mg/1 Capsule | Novel Laboratories, Inc. | ANDA · DEA CII |
| 68071-2368 | Oxycodone Hydrochloride 5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CII |
| 68071-2899 | Oxycodone Hydrochloride 5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CII |
| 68071-3600 | Oxycodone Hydrochloride 5 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CII |
| 0121-0827 | Oxycodone Hydrochloride 5 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | ANDA · DEA CII |
| 0121-4827 | Oxycodone Hydrochloride 5 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | ANDA · DEA CII |
| 68094-005 | Oxycodone Hydrochloride 15 mg/1 Tablet | Precision Dose, Inc. | ANDA · DEA CII |
| 70752-136 | Oxycodone Hydrochloride 5 mg/5mL Solution | QUAGEN PHARMACEUTICALS LLC | ANDA · DEA CII |
| 70752-137 | Oxycodone Hydrochloride 100 mg/5mL Solution | QUAGEN PHARMACEUTICALS LLC | ANDA · DEA CII |
| 55700-174 | Oxycodone Hydrochloride 15 mg/1 Tablet | Quality Care Products LLC | ANDA · DEA CII |
| 67296-2233 | Oxycodone Hydrochloride 5 mg/1 Tablet | Redpharm Drug | ANDA · DEA CII |
| 67296-2188 | Oxycodone Hydrochloride 5 mg/1 Tablet | Redpharm Drug | ANDA · DEA CII |
| 67296-0425 | Oxycodone Hydrochloride 5 mg/1 Tablet | Redpharm Drug | ANDA · DEA CII |
| 42858-005 | Oxycodone Hydrochloride 30 mg/1 Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-004 | Oxycodone Hydrochloride 20 mg/1 Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-003 | Oxycodone Hydrochloride 15 mg/1 Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-002 | Oxycodone Hydrochloride 10 mg/1 Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-001 | Oxycodone Hydrochloride 5 mg/1 Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 0406-8557 | Oxycodone Hydrochloride 100 mg/5mL Solution | SpecGx LLC | ANDA · DEA CII |
| 0406-8556 | Oxycodone Hydrochloride 5 mg/5mL Solution | SpecGx LLC | ANDA · DEA CII |
| 0406-8530 | Oxycodone Hydrochloride 30 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-8520 | Oxycodone Hydrochloride 20 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-8515 | Oxycodone Hydrochloride 15 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-8510 | Oxycodone Hydrochloride 10 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-0552 | Oxycodone Hydrochloride 5 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 60760-957 | Oxycodone Hydrochloride 15 mg/1 Tablet | ST. MARY'S MEDICAL PARK PHARMACY | ANDA · DEA CII |
| 60760-954 | Oxycodone Hydrochloride 5 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA · DEA CII |
| 60760-955 | Oxycodone Hydrochloride 10 mg/1 Tablet | ST. MARY'S MEDICAL PARK PHARMACY | ANDA · DEA CII |
| 60760-967 | Oxycodone Hydrochloride 15 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA · DEA CII |
| 60760-966 | Oxycodone Hydrochloride 10 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA · DEA CII |
| 60760-956 | Oxycodone Hydrochloride 15 mg/1 Tablet | ST. MARY'S MEDICAL PARK PHARMACY | ANDA · DEA CII |
| 64380-263 | Oxycodone Hydrochloride 30 mg/1 Tablet | Strides Pharma Science Limited | ANDA · DEA CII |
| 64380-262 | Oxycodone Hydrochloride 20 mg/1 Tablet | Strides Pharma Science Limited | ANDA · DEA CII |
| 64380-261 | Oxycodone Hydrochloride 15 mg/1 Tablet | Strides Pharma Science Limited | ANDA · DEA CII |
| 64380-260 | Oxycodone Hydrochloride 10 mg/1 Tablet | Strides Pharma Science Limited | ANDA · DEA CII |
| 64380-259 | Oxycodone Hydrochloride 5 mg/1 Tablet | Strides Pharma Science Limited | ANDA · DEA CII |
| 72865-128 | Oxycodone Hydrochloride 15 mg/1 Tablet | XLCare Pharmaceuticals, Inc | ANDA · DEA CII |
| 72865-129 | Oxycodone Hydrochloride 30 mg/1 Tablet | XLCare Pharmaceuticals, Inc | ANDA · DEA CII |
| 64950-354 | Oxycodone Hydrochloride 5 mg/5mL Solution | Genus Lifesciences Inc. | NDA · DEA CII |
| 67296-2167 | Oxycodone Hydrochloride 5 mg/5mL Solution | Redpharm Drug | NDA · DEA CII |
| 0115-1560 | Oxycodone Hydrochloride 40 mg/1 Tablet, Film Coated, Extended Release | Amneal Pharmaceuticals of New York LLC | NDA AUTHORIZED GENERIC · DEA CII |
Oxycodone Hydrochloride recalls
- D-0338-2026 Feb 18, 2026 · Class II · Ongoing
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. - D-0652-2022 Mar 16, 2022 · Class II · Terminated
Impurity failure at 0-time of the repackaged lot. - D-0358-2022 Jan 12, 2022 · Class III · Terminated
Out-of-specification impurity test result observed at 18-month long term stability time point. - D-0794-2021 Sep 22, 2021 · Class II · Terminated
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle - D-0231-2021 Jan 20, 2021 · Class III · Terminated
Presence of Foreign Substance: Particulate matter was found in multiple lots of product. - D-0248-2018 Feb 7, 2018 · Class III · Terminated
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol - D-1441-2016 Jul 20, 2016 · Class III · Terminated
Failed Impurities/Degradation Specification; 9 month stability
Frequently asked questions
What is Oxycodone Hydrochloride used for?
Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an…
What are the side effects of Oxycodone Hydrochloride?
The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.2) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.3) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.4) ] Neonatal Opioid Withdrawal Syndrome [see Warnings… See the full label for the complete list.
Who makes Oxycodone Hydrochloride?
Oxycodone Hydrochloride is listed by 35 labelers in the FDA NDC directory, including Alvogen, Inc., American Health Packaging, Amneal Pharmaceuticals LLC, ANI Pharmaceuticals, Inc..
Has Oxycodone Hydrochloride been recalled?
The FDA enforcement database lists 7 recalls for Oxycodone Hydrochloride, most recently D-0338-2026 (class ii): Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.