Hydrocodone Bitartrate and Acetaminophen
Tablet · Oral
Uses
Hydrocodone bitartrate and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative 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 ], reserve opioid analgesics, including hydrocodone bitartrate and acetaminophen 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.
Dosage and administration
DOSAGE AND ADMINISTRATION . Important Dosage and Administration Instructions Ensure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate and acetaminophen oral solution to avoid dosing errors due to confusion between mg and mL, and with other hydrocodone bitartrate and acetaminophen oral 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 the correct dose of hydrocodone bitartrate and acetaminophen oral solution. Strongly advise patients and caregivers to always use a graduated oral syringe or measuring cup, with metric units of measurements (i.e., mL) to correctly measure the prescribed amount of medication. Inform patients and caregivers that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure hydrocodone bitartrate and acetaminophen oral solution. Hydrocodone bitartrate and acetaminophen 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 consistent with individual patient treatment goals [see WARNINGS ]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of hydrocodone bitartrate and acetaminophen oral solution for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher does 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 ]. Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with hydrocodone bitartrate and acetaminophen oral solution. Consider this risk when selecting an initial dose and when making dose adjustments [see WARNINGS ]. 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. The presence of risk factors for overdose should not prevent the management of pain in any patient [see WARNINGS; Addiction, Abuse, and Misuse ; Life-Threatening Respiratory Depression ; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants ]. Discuss the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program). There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics. Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent. Initial Dosage Use of Hydrocodone Bitartrate and Acetaminophen Oral Solution as the First Opioid Analgesic Hydrocodone bitartrate and acetaminophen oral solution contains 10 mg of hydrocodone bitartrate and 300 mg of acetaminophen per 15 mL. Initiate treatment with hydrocodone bitartrate and acetaminophen oral solution at a dose of 11.25 milliliters (equivalent to 7.5 mg hydrocodone bitartrate) every 4 to 6 hours as needed for pain. Titrate the dose based upon the individual patient’s response to their initial dose of hydrocodone bitartrate and acetaminophen oral solution. The total daily dosage for adults should not exceed 67.5 milliliters (equivalent to 45 mg hydrocodone bitartrate). The table below displays pediatric maximum total daily dose, and the dose to be given every 4 to 6 hours as needed for pain, based on age and body weight. Dosing in children should not exceed 6 doses per day and should not exceed the maximum amounts per dose nor the maximum total daily doses displayed in the table. These dosages correspond to an average individual dose of 0.20 mL/kg of hydrocodone bitartrate and acetaminophen oral solution (providing 0.135 mg/kg of hydrocodone bitartrate and 4 mg/kg of acetaminophen). Dosing should be based on weight whenever possible. However, for pediatric patients weighing 101 lbs. (46 kg) and up, do not exceed the total daily dose of 67.5 mL (45 mg hydrocodone bitartrate) and do not exceed a single dose greater than 11.25 mL (7.5 mg hydrocodone bitartrate). Doses above these amounts would exceed the maximum doses for adults. It is of utmost importance that the dose of hydrocodone bitartrate and acetaminophen oral solution be administered accurately [see DOSAGE AND ADMINISTRATION ; Important Dosage and Administration Instructions ]. BODY WEIGHT APPROXIMATE AGE DOSE every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE (6 doses per day) 12 to 15 kg 27 to 34 lbs. 2 to 3 years 2.8 mL 16.8 mL 16 to 22 kg 35 to 50 lbs.
Contraindications
Hydrocodone bitartrate and acetaminophen oral solution is contraindicated in patients with: Significant respiratory depression [see WARNINGS ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see WARNINGS , ADVERSE REACTIONS ]
Warnings
WARNINGS . 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 hydrocodone bitartrate and acetaminophen oral solutions of different concentrations, when prescribing, dispensing, and administering hydrocodone bitartrate and acetaminophen oral solution. Ensure that the dose is communicated clearly and dispensed accurately. Instruct patients and caregivers on how to measure and administer the correct dose of hydrocodone bitartrate and acetaminophen oral solution and to use extreme caution when measuring the dose. Strongly advise patients and caregivers to obtain and always use a graduated device that can measure and deliver the prescribed dose accurately, and to never use household teaspoons or tablespoons to measure a dose because these are not accurate measuring devices. Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen oral solution contains hydrocodone, a Schedule II controlled substance. As an opioid, hydrocodone bitartrate and acetaminophen oral solution exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and acetaminophen 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 ]. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing hydrocodone bitartrate and acetaminophen oral solution, and reassess all patients receiving hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen oral solution, but use in such patients necessitates intensive counseling about the risks and proper use of hydrocodone bitartrate and acetaminophen oral solution along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider recommending or prescribing an opioid overdose reversal agent [see WARNINGS , DOSAGE AND ADMINISTRATION ]. Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Consider these risks when prescribing or dispensing hydrocodone bitartrate and acetaminophen 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 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. 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 ]. Carbon dioxide (CO 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 hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen oral solution are essential [see DOSAGE AND ADMINISTRATION ]. Overestimating the hydrocodone bitartrate and acetaminophen oral solution dosage when converting patients from another opioid product can result in a fatal overdose. Accidental ingestion of even one dose of hydrocodone bitartrate and acetaminophen oral solution especially by children, can result in respiratory depression and death due to an overdose of hydrocodone bitartrate and acetaminophen oral solution. 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 PRECAUTIONS; Information for Patients/Caregivers ]. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see DOSAGE AND ADMINISTRATION ]. 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).
Precautions
PRECAUTIONS . Risks of Driving and Operating Machinery Hydrocodone bitartrate and acetaminophen oral solution may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of hydrocodone bitartrate and acetaminophen oral solution and know how they will react to the medication [see PRECAUTIONS; Information for Patients/Caregivers ]. Information for Patients/Caregivers 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 hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen oral solution unsecured can pose a deadly risk to others in the home [see WARNINGS , DRUG ABUSE AND DEPENDENCE ]. Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused hydrocodone bitartrate and acetaminophen 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 Strongly advise patients and caregivers to always use a graduated oral syringe or measuring cup, with metric units of measurements (i.e., mL), to correctly measure the prescribed amount of medication. Inform patients and caregivers that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure hydrocodone bitartrate and acetaminophen oral solution [see WARNINGS ]. If the prescribed concentration is changed, instruct patients 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 hydrocodone bitartrate and acetaminophen oral solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ]. Instruct patients not to share hydrocodone bitartrate and acetaminophen oral solution with others and to take steps to protect hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen 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; Life-Threatening Respiratory Depression ]. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS ] . Interactions with Benzodiazepines and Other Central Nervous System (CNS) Depressants Inform patients and caregivers that potentially fatal additive effects may occur if hydrocodone bitartrate and acetaminophen oral solution is used with benzodiazepines and 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 , PRECAUTIONS; Drug Interactions ]. 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 WARNINGS , DOSAGE AND ADMINISTRATION ]. Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to 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 ]. 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 their opioid overdose 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 the 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.
Side effects
The following adverse reactions have been identified during post approval use of hydrocodone bitartrate and acetaminophen oral solution. Because these reactions are 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. The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea and vomiting. Other adverse reactions include: Cardio-Renal: Bradycardia, cardiac arrest, circulatory collapse, renal toxicity, renal tubular necrosis, hypotension. Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, lightheadedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma. Endocrine: Hypoglycemic coma. Gastrointestinal System: Abdominal pain, constipation, gastric distress, heartburn, hepatic necrosis, hepatitis, occult blood loss, nausea, peptic ulcer, and vomiting. Genitourinary System: Spasm of vesical sphincters, ureteral spasm, and urinary retention. Hematologic: Agranulocytosis, hemolytic anemia, iron deficiency anemia, prolonged bleeding time, thrombocytopenia. Hypersensitivity: Allergic reactions. Musculoskeletal: Skeletal muscle flaccidity. Respiratory Depression: Acute airway obstruction, apnea, dose-related respiratory depression [see OVERDOSAGE ], shortness of breath. Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. Skin: Cold and clammy skin, diaphoresis, pruritus, rash. 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 hydrocodone bitartrate and acetaminophen oral solution. Androgen deficiency : Cases of androgen deficiency have occurred with use of opioids for an extended period of time [see CLINICAL PHARMACOLOGY ]. Hyperalgesia and Allodynia: Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see WARNINGS ]. 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 ]. 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 ], respectively, as measured with a validated self-reported instrument. A retrospective, observational cohort study estimated the risk of opioid-involved overdose or opioid overdose-related death in patients with new long-term use of Schedule II opioid analgesics from 2006 through 2016 (n=220,249). Included patients had been enrolled in either one of two commercial insurance programs, one managed care program, or one Medicaid program for at least 9 months. New long-term use was defined as having Schedule II opioid analgesic prescriptions covering at least 70 days’ supply over the 3 months prior to study entry and none during the preceding 6 months. Patients were excluded if they had an opioid-involved overdose in the 9 months prior to study entry. Overdose was measured using a validated medical code-based algorithm with linkage to the National Death Index database. The 5-year cumulative incidence estimates for opioid-involved overdose or opioid overdose-related death ranged from approximately 1.5% to 4% across study sites, counting only the first event during follow-up. Approximately 17% of first opioid overdoses observed over the entire study period (5-11 years, depending on the study site) were fatal. Higher baseline opioid dose was the strongest and most consistent predictor of opioid-involved overdose or opioid overdose-related death. Study exclusion criteria may have selected patients at lower risk of overdose, and substantial loss to follow-up (approximately 80%) also may have biased estimates. The risk estimates from the studies described above may not be generalizable to all patients receiving opioid analgesics, such as those with exposures shorter or longer than the duration evaluated in the studies.
Drug interactions
Drug Interactions Inhibitors of CYP3A4 and CYP2D6 The concomitant use of hydrocodone bitartrate and acetaminophen oral solution and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of hydrocodone from hydrocodone bitartrate and acetaminophen oral solution, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of hydrocodone bitartrate and acetaminophen oral solution and both CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of hydrocodone bitartrate and acetaminophen oral solution is achieved [see WARNINGS ]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, hydrocodone plasma concentration will decrease [see CLINICAL PHARMACOLOGY ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to hydrocodone bitartrate and acetaminophen oral solution. If concomitant use is necessary, consider dosage reduction of hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen oral solution dosage until stable drug effects are achieved. Assess patients for signs or symptoms of opioid withdrawal. Inducers of CYP3A4 The concomitant use of hydrocodone bitartrate and acetaminophen oral solution and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of hydrocodone [see CLINICAL PHARMACOLOGY ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to [see WARNINGS ]. After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [see CLINICAL PHARMACOLOGY ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. If concomitant use is necessary, consider increasing the hydrocodone bitartrate and acetaminophen oral solution dosage until stable drug effects are achieved [see DOSAGE AND ADMINISTRATION ]. Assess for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider hydrocodone bitartrate and acetaminophen oral solution dosage reduction and evaluate patients at frequent intervals for signs of respiratory depression and sedation. Benzodiazepines and Other CNS Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants such as benzodiazepines and other sedative/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapenitoids (gabapentin or pregabalin), other opioids, and alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.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 an opioid overdose reversal agent [see WARNINGS , DOSAGE AND ADMINISTRATION ]. Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as 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), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see PRECAUTIONS; Information for Patients/Caregivers ]. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue hydrocodone bitartrate and acetaminophen oral solution if serotonin syndrome is suspected. Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, or linezolid, may manifest as serotonin syndrome, or opioid toxicity (e.g., respiratory depression, coma) [see WARNINGS ]. The use of hydrocodone bitartrate and acetaminophen 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. Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of hydrocodone bitartrate and acetaminophen oral solution and/or precipitate withdrawal symptoms. Advise patient to avoid concomitant use of these drugs. Muscle Relaxants Hydrocodone may enhance the neuromuscular blocking action of skeletal muscle relaxants (e.g., cyclobenzaprine, metaxalone) and produce an increased degree of respiratory depression.Because respiratory depression may be greater than otherwise expected, decrease the dosage of hydrocodone bitartrate and acetaminophen oral solution and/or the muscle relaxant as necessary.
Pregnancy
Pregnancy Teratogenic Effects There are no adequate and well-controlled studies in pregnant women. Hydrocodone bitartrate and acetaminophen oral solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects 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 ].
Pediatric use
Pediatric Use The safety and effectiveness of hydrocodone bitartrate and acetaminophen oral solution in the pediatric population below the age of two years have not been established. Use of hydrocodone bitartrate and acetaminophen oral solution in the pediatric patients over the age of 2 years is supported by evidence from adequate and well controlled studies of hydrocodone and acetaminophen combination products in adults, along with additional data which support the development of metabolic pathways in children two years of age and over [see DOSAGE AND ADMINISTRATION ] for pediatric dosage information.
Geriatric use
Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to hydrocodone bitartrate and acetaminophen oral solution. In general, use caution when selecting a dosage 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 hydrocodone bitartrate and acetaminophen oral solution slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see WARNINGS ]. Hydrocodone and acetaminophen are 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
Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Clinical Presentation Acute overdose with hydrocodone bitartrate and acetaminophen oral solution 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 ]. Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication. Acetaminophen Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Treatment of Overdose Hydrocodone 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 hydrocodone in hydrocodone bitartrate and acetaminophen oral solution carefully monitor the patient until spontaneous respiration is reliably reestablished. 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. Acetaminophen Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease absorption if acetaminophen is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration. Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose-dependent and occurs in the course of intoxication.
Description
Hydrocodone bitartrate and acetaminophen are available in liquid form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Hydrocodone bitartrate and acetaminophen oral solution contains: Per 5 mL Per 15 mL Hydrocodone Bitartrate 3.33 mg 10 mg Acetaminophen 100 mg 300 mg Alcohol 7% 7% In addition, the liquid contains the following inactive ingredients: citric acid anhydrous, ethyl maltol, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with D&C Red #33 and FD&C Red #40 as coloring and natural and artificial flavoring. hydrocodone bitartrate chemical structure acetaminophen chemical structure
Mechanism of action
Mechanism of Action Hydrocodone is a semi-synthetic opioid agonist with relative selectivity for the mu-opioid (μ) receptor, although it can interact with other opioid receptors at higher doses. Hydrocodone acts as a full agonist, binding to and activating opioid receptors at sites in the peri-aquaductal and peri-ventricular gray matter, the ventro-medial medulla and the spinal cord to produce analgesia. The analgesia, as well as the euphoriant, respiratory depressant and physiologic dependence properties of μ agonist opioids like hydrocodone, result principally from agonist action at the μ receptors. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.
How supplied
Hydrocodone bitartrate and acetaminophen oral solution, each 15 mL of which contains hydrocodone bitartrate 10 mg, acetaminophen 300 mg, and alcohol 7%, is supplied as a red-colored, tropical fruit punch-flavored liquid, in 16 fl. oz. (473 mL) bottles, NDC 0054-0843-63. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Store hydrocodone bitartrate and acetaminophen oral solution securely and dispose of properly [see PRECAUTIONS; Information for Patients/Caregivers ]. Manufactured by: Mikart, LLC Atlanta, GA 30318 Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Rev. 11/2025 Code 1277B00 H/02
Patient information
Information for Patients/Caregivers 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 hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen oral solution unsecured can pose a deadly risk to others in the home [see WARNINGS , DRUG ABUSE AND DEPENDENCE ]. Advise patients and caregivers that when medicines are no longer needed, they should be disposed of promptly. Expired, unwanted, or unused hydrocodone bitartrate and acetaminophen 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 Strongly advise patients and caregivers to always use a graduated oral syringe or measuring cup, with metric units of measurements (i.e., mL), to correctly measure the prescribed amount of medication. Inform patients and caregivers that oral dosing devices may be obtained from their pharmacy and to never use household teaspoons or tablespoons to measure hydrocodone bitartrate and acetaminophen oral solution [see WARNINGS ]. If the prescribed concentration is changed, instruct patients 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 hydrocodone bitartrate and acetaminophen oral solution, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see WARNINGS ]. Instruct patients not to share hydrocodone bitartrate and acetaminophen oral solution with others and to take steps to protect hydrocodone bitartrate and acetaminophen 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 hydrocodone bitartrate and acetaminophen 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; Life-Threatening Respiratory Depression ]. Accidental Ingestion Inform patients that accidental ingestion, especially by children, may result in respiratory depression or death [see WARNINGS ] . Interactions with Benzodiazepines and Other Central Nervous System (CNS) Depressants Inform patients and caregivers that potentially fatal additive effects may occur if hydrocodone bitartrate and acetaminophen oral solution is used with benzodiazepines and 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 , PRECAUTIONS; Drug Interactions ]. 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 WARNINGS , DOSAGE AND ADMINISTRATION ]. Educate patients and caregivers on how to recognize the signs and symptoms of an overdose. Explain to 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 ]. 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 their opioid overdose 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 the 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. Advise patients to seek medical attention if they experience symptoms of hyperalgesia, including worsening pain, increased sensitivity to pain, or new pain [see WARNINGS , ADVERSE REACTIONS ]. Serotonin Syndrome Inform patients that hydrocodone bitartrate and acetaminophen oral solution could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop.
Label text from the FDA structured product label by Hikma Pharmaceuticals USA Inc. (revised Jul 28, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Hydrocodone Bitartrate in 203 products
- Acetaminophen in 203 products
Hydrocodone Bitartrate and Acetaminophen NDC products (203)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-1778 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | A-S Medication Solutions | ANDA · DEA CII |
| 60687-418 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | American Health Packaging | ANDA · DEA CII |
| 60687-417 | Hydrocodone Bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL Solution | American Health Packaging | ANDA · DEA CII |
| 60687-407 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | American Health Packaging | ANDA · DEA CII |
| 60687-396 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | American Health Packaging | ANDA · DEA CII |
| 65162-115 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Amneal Pharmaceuticals LLC | ANDA · DEA CII |
| 53746-109 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 53746-110 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA · DEA CII |
| 87063-049 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 87063-051 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 87063-050 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-215 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-877 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-876 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-875 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-257 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 76420-133 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Asclemed USA, Inc. | ANDA · DEA CII |
| 13107-019 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 13107-020 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 13107-021 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 13107-211 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 300 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 13107-212 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 13107-213 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 300 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 50268-402 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | AvPAK | ANDA · DEA CII |
| 50268-400 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | AvPAK | ANDA · DEA CII |
| 50268-401 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | AvPAK | ANDA · DEA CII |
| 71335-1557 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2297 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-8886 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2298 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2299 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2300 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2308 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2103 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1970 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1811 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2309 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2310 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2468 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2469 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2471 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1470 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1444 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1419 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1418 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1417 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1339 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-1271 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-0108 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2470 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-8885 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-8499 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-5422 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1342 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-9737 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1279 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1280 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1281 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1287 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1288 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1289 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1341 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-9736 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1989 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1990 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1991 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1996 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1997 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1998 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-2271 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2104 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-9735 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-9734 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-9602 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2969 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2740 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2585 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2238 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2195 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2144 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2118 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2117 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2116 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2115 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2112 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 71335-2105 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2295 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2296 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1177 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1179 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1180 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1181 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1183 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1184 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 300 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1939 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1940 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2292 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2293 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2294 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-1938 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 31722-940 | Hydrocodone Bitartrate 2.5 mg/1; Acetaminophen 325 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-942 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-996 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 31722-997 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Camber Pharmaceuticals, Inc. | ANDA · DEA CII |
| 27808-049 | Hydrocodone Bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL Solution | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 27808-130 | Hydrocodone Bitartrate 10 mg/15mL; Acetaminophen 300 mg/15mL Solution | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 27808-116 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 300 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 27808-115 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 27808-114 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 300 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 27808-037 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 27808-036 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 27808-035 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 72189-343 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Direct Rx | ANDA · DEA CII |
| 72189-191 | Acetaminophen 325 mg/1; Hydrocodone Bitartrate 7.5 mg/1 Tablet | DirectRx | ANDA · DEA CII |
| 72189-348 | Acetaminophen 325 mg/1; Hydrocodone Bitartrate 10 mg/1 Tablet | DirectRx | ANDA · DEA CII |
| 64850-630 | Hydrocodone Bitartrate 2.5 mg/1; Acetaminophen 325 mg/1 Tablet | Elite Laboratories, Inc. | ANDA · DEA CII |
| 64850-631 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Elite Laboratories, Inc. | ANDA · DEA CII |
| 64850-632 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Elite Laboratories, Inc. | ANDA · DEA CII |
| 64850-633 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Elite Laboratories, Inc. | ANDA · DEA CII |
| 42806-113 | Acetaminophen 325 mg/1; Hydrocodone Bitartrate 10 mg/1 Tablet | Epic Pharma, LLC | ANDA · DEA CII |
| 42806-111 | Acetaminophen 325 mg/1; Hydrocodone Bitartrate 5 mg/1 Tablet | Epic Pharma, LLC | ANDA · DEA CII |
| 42806-112 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Epic Pharma, LLC | ANDA · DEA CII |
| 71930-044 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 300 mg/1 Tablet | Eywa Pharma Inc | ANDA · DEA CII |
| 71930-043 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 Tablet | Eywa Pharma Inc | ANDA · DEA CII |
| 71930-042 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 300 mg/1 Tablet | Eywa Pharma Inc | ANDA · DEA CII |
| 71930-027 | Hydrocodone Bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL Solution | Eywa Pharma Inc | ANDA · DEA CII |
| 71930-021 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Eywa Pharma Inc | ANDA · DEA CII |
| 71930-020 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Eywa Pharma Inc | ANDA · DEA CII |
| 71930-019 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Eywa Pharma Inc | ANDA · DEA CII |
| 64950-343 | Hydrocodone Bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL Solution | Genus Lifesciences Inc. | ANDA · DEA CII |
| 64950-373 | Hydrocodone Bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL Solution | Genus Lifesciences Inc. | ANDA · DEA CII |
| 60429-590 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA · DEA CII |
| 70010-672 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-674 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 70010-673 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Granules Pharmaceuticals Inc. | ANDA · DEA CII |
| 0054-0843 | Hydrocodone Bitartrate 10 mg/15mL; Acetaminophen 300 mg/15mL Liquid | Hikma Pharmaceuticals USA Inc. | ANDA · DEA CII |
| 10702-192 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 300 mg/1 Tablet | KVK-Tech, Inc. | ANDA · DEA CII |
| 10702-189 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | KVK-Tech, Inc. | ANDA · DEA CII |
| 10702-190 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | KVK-Tech, Inc. | ANDA · DEA CII |
| 10702-194 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 300 mg/1 Tablet | KVK-Tech, Inc. | ANDA · DEA CII |
| 10702-193 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 Tablet | KVK-Tech, Inc. | ANDA · DEA CII |
| 10702-191 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | KVK-Tech, Inc. | ANDA · DEA CII |
| 43386-351 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 300 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-352 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-356 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-353 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 300 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-357 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-358 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 68071-3685 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 66267-319 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CII |
| 68071-2494 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CII |
| 68071-2645 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CII |
| 68071-3447 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CII |
| 68071-4801 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CII |
| 68071-4853 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CII |
| 68071-4941 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | NuCare Pharmaceuticals,Inc. | ANDA · DEA CII |
| 0121-1544 | Hydrocodone Bitartrate 5 mg/10mL; Acetaminophen 217 mg/10mL Solution | PAI Holdings, LLC dba PAI Pharma | ANDA · DEA CII |
| 0121-2316 | Hydrocodone Bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL Solution | PAI Holdings, LLC dba PAI Pharma | ANDA · DEA CII |
| 0121-4772 | Hydrocodone Bitartrate 2.5 mg/5mL; Acetaminophen 108 mg/5mL Solution | PAI Holdings, LLC dba PAI Pharma | ANDA · DEA CII |
| 82804-116 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CII |
| 82804-003 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CII |
| 63187-778 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CII |
| 82804-306 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CII |
| 63187-120 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CII |
| 63187-112 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CII |
| 71205-660 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CII |
| 63187-658 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CII |
| 63187-375 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Proficient Rx LP | ANDA · DEA CII |
| 55700-992 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Quality Care Products, LLC | ANDA · DEA CII |
| 55700-991 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Quality Care Products, LLC | ANDA · DEA CII |
| 67296-2201 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Redpharm Drug | ANDA · DEA CII |
| 67296-2166 | Hydrocodone Bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL Solution | Redpharm Drug | ANDA · DEA CII |
| 67296-2093 | Hydrocodone Bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL Solution | Redpharm drug | ANDA · DEA CII |
| 67296-1890 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | RedPharm Drug, Inc | ANDA · DEA CII |
| 42858-202 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-201 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 42858-203 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Rhodes Pharmaceuticals LLC | ANDA · DEA CII |
| 0406-0377 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-0376 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 300 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-0378 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 300 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-0123 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-0124 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-0125 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 60760-873 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA · DEA CII |
| 60760-872 | Acetaminophen 325 mg/1; Hydrocodone Bitartrate 10 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA · DEA CII |
| 60760-871 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | ST. MARY'S MEDICAL PARK PHARMACY | ANDA · DEA CII |
| 60760-870 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | St. Mary's Medical Park Pharmacy | ANDA · DEA CII |
| 60760-692 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | ST. MARY'S MEDICAL PARK PHARMACY | ANDA · DEA CII |
| 64380-442 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Strides Pharma Science Limited | ANDA · DEA CII |
| 64380-440 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Strides Pharma Science Limited | ANDA · DEA CII |
| 64380-441 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Strides Pharma Science Limited | ANDA · DEA CII |
| 63304-497 | Acetaminophen 325 mg/1; Hydrocodone Bitartrate 10 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA · DEA CII |
| 0245-0412 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 0245-0411 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 0245-0410 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | Upsher-Smith Laboratories, LLC | ANDA · DEA CII |
| 72865-202 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 72865-203 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 72865-204 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 72865-201 | Hydrocodone Bitartrate 2.5 mg/1; Acetaminophen 325 mg/1 Tablet | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 72865-112 | Hydrocodone Bitartrate 10 mg/1; Acetaminophen 325 mg/1 Tablet | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 72865-111 | Hydrocodone Bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 Tablet | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 72865-110 | Hydrocodone Bitartrate 5 mg/1; Acetaminophen 325 mg/1 Tablet | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
| 72865-109 | Hydrocodone Bitartrate 2.5 mg/1; Acetaminophen 325 mg/1 Tablet | XLCare Pharmaceuticals, Inc. | ANDA · DEA CII |
Hydrocodone Bitartrate and Acetaminophen recalls
- D-0276-2022 Dec 15, 2021 · Class II · Terminated
Product Mix-up - D-0836-2018 Jun 6, 2018 · Class III · Terminated
Labeling: Missing Label
Frequently asked questions
What is Hydrocodone Bitartrate and Acetaminophen used for?
Hydrocodone bitartrate and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative 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 ], reserve opioid…
What are the side effects of Hydrocodone Bitartrate and Acetaminophen?
The following adverse reactions have been identified during post approval use of hydrocodone bitartrate and acetaminophen oral solution. Because these reactions are 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. The most frequently reported adverse reactions are… See the full label for the complete list.
Who makes Hydrocodone Bitartrate and Acetaminophen?
Hydrocodone Bitartrate and Acetaminophen is listed by 37 labelers in the FDA NDC directory, including A-S Medication Solutions, American Health Packaging, Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York LLC.
Has Hydrocodone Bitartrate and Acetaminophen been recalled?
The FDA enforcement database lists 2 recalls for Hydrocodone Bitartrate and Acetaminophen, most recently D-0276-2022 (class ii): Product Mix-up