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Hydrocodone Bitartrate and Acetaminophen

Prescription ANDA Schedule CII TE AA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Hydrocodone Bitartrate and Acetaminophen
Generic name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Bryant Ranch Prepack
Product type
Human Prescription Drug
DEA schedule
CII
Active ingredients
6
NDC product codes
194
Packages
620
Data completeness
83% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Acetaminophen 300 mg/1 313782 View
Acetaminophen 325 mg/1 313782 View
Hydrocodone Bitartrate 10 mg/1 856999 View
Hydrocodone Bitartrate 2.5 mg/1 856999 View
Hydrocodone Bitartrate 5 mg/1 856999 View
Hydrocodone Bitartrate 7.5 mg/1 856999 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
400

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Opioid Agonist [EPC] EPC All 109 members
Opioid Agonists [MoA] MoA All 35 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
202214
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 27, 2013
Sponsor
TRIS PHARMA INC
Products on application
6
Submissions recorded
17
Products approved under application 202214.
Product Trade name Form Strength Ingredient Status TE Flags
202214-001 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ACETAMINOPHEN; HYDROCODONE BITARTRATE Prescription AA
202214-002 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ACETAMINOPHEN; HYDROCODONE BITARTRATE Prescription AA
202214-003 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ACETAMINOPHEN; HYDROCODONE BITARTRATE Prescription AA
202214-004 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ACETAMINOPHEN; HYDROCODONE BITARTRATE Prescription AA
202214-005 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ACETAMINOPHEN; HYDROCODONE BITARTRATE Prescription AA
202214-006 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET ACETAMINOPHEN; HYDROCODONE BITARTRATE Prescription AA

Therapeutic equivalence

Source: Orange Book
TE code
AA
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — no known or suspected bioequivalence problems (conventional dosage forms)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 202214.
Type No. Action Status Date Review
Supplement 27 REMS Approved June 18, 2026 —
Supplement 26 Labeling Approved December 22, 2025 Standard
Supplement 20 Labeling Approved December 22, 2025 Standard
Supplement 21 REMS Approved October 31, 2024 —
Supplement 18 Labeling Approved December 15, 2023 Standard
Supplement 17 Labeling Approved December 15, 2023 Standard
Supplement 14 Labeling Approved March 4, 2021 Standard
Supplement 10 Labeling Approved October 11, 2019 Standard
Supplement 9 Labeling Approved September 21, 2018 Standard
Supplement 8 REMS Approved September 18, 2018 —
Supplement 7 Labeling Approved September 12, 2018 Standard
Supplement 5 Labeling Approved September 12, 2018 Standard
Supplement 4 Labeling Approved December 16, 2016 Standard
Supplement 3 Labeling Approved December 16, 2016 Standard
Supplement 2 Manufacturing (CMC) Approved March 15, 2016 Unknown
Supplement 1 Labeling Approved October 18, 2013 Standard
Original application 1 Approved March 27, 2013 —

Review documents

  • 0 · Original application · November 3, 2023

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260608). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20260608 HUMAN PRESCRIPTION DRUG · 20260513 HUMAN PRESCRIPTION DRUG · 20260205 HUMAN PRESCRIPTION DRUG · 20251022

Boxed Warning

openFDA Drug Labeling

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Acetaminophen Tablet exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Hydrocodone Bitartrate and Acetaminophen Tablets, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS ]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [see Warnings ]. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to • complete a REMS-compliant education program, • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and • consider other tools to improve patient, household, and community safety. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Hydrocodone Bitartrate and Acetaminophen Tablets. Monitor for respiratory depression, especially during initiation of Hydrocodone Bitartrate and Acetaminophen Tablets or following a dose increase [see WARNINGS ]. Accidental Ingestion Accidental ingestion of even one dose of Hydrocodone Bitartrate and Acetaminophen Tablets especially by children, can result in a fatal overdose of Hydrocodone Bitartrate and Acetaminophen Tablets [see WARNINGS ]. Neonatal Opioid Withdrawal Syndrome Prolonged use of Hydrocodone Bitartrate and Acetaminophen Tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS ]. Cytochrome P450 3A4 Interaction The concomitant use of Hydrocodone Bitartrate and Acetaminophen Tablets with all cytochrome P450 3A4 inhibitors may result in an increase in Hydrocodone Bitartrate and Acetaminophen Tablets plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in Hydrocodone Bitartrate and Acetaminophen Tablets plasma concentrations. Monitor patients receiving Hydrocodone Bitartrate and Acetaminophen Tablets and any Cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation [see CLINICAL PHARMACOLOGY , WARNINGS , PRECAUTIONS; Drug Interactions ]. Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen containing product.[see WARNINGS, OVERDOSAGE ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, …

Indications and Usage

openFDA Drug Labeling

INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablets, USP are 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, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS ] , reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia Hydrocodone bitartrate and acetaminophen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Dosage and Administration

openFDA Drug Labeling

DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions Hydrocodone Bitartrate and Acetaminophen Tablets 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 ]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Hydrocodone Bitartrate and Acetaminophen Tablets 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 ]. Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Hydrocodone Bitartrate and Acetaminophen Tablets. 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 Tablets as the First Opioid Analgesic 7.5 mg/325 mg Initiate treatment with Hydrocodone Bitartrate and Acetaminophen Tablets with 1 tablet every 4 to 6 hours as needed for pain, at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of Hydrocodone Bitartrate and Acetaminophen Tablets. The total daily dosage should not exceed 6 tablets. Conversion from Other Opioids to Hydrocodone Bitartrate and Acetaminophen Tablets There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of Hydrocodone Bitartrate and Acetaminophen Tablets. It is safer to underestimate a patient’s 24-hour Hydrocodone Bitartrate and Acetaminophen Tablets dosage than to overestimate the 24-hour Hydrocodone Bitartrate and Acetaminophen Tablets dosage and manage an adverse reaction due …

Contraindications

openFDA Drug Labeling

CONTRAINDICATIONS Hydrocodone Bitartrate and Acetaminophen Tablets, USP are 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 Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, a Schedule II controlled substance. As an opioid, hydrocodone bitartrate and acetaminophen tablets expose 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 patient’s appropriately prescribed hydrocodone bitartrate and acetaminophen tablets. 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 [Adverse Reactions; Postmarketing Experience]. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing hydrocodone bitartrate and acetaminophen tablets, and reassess all patients receiving hydrocodone bitartrate and acetaminophen tablets 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 tablets, but use in such patients necessitates intensive counseling about the risks and proper use of hydrocodone bitartrate and acetaminophen tablets along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider prescribing an opioid overdose reversal agent [see Warnings, Life-Threatening Respiratory Depression; Dosage and Administration, Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose]. 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 tablets. 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 antagonists, 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 tablets, 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 tablets are essential [see Dosage and Administration]. Overestimating the hydrocodone bitartrate and acetaminophen tablets 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 tablets, especially by children, can result in respiratory depression and death due to an overdose of hydrocodone bitartrate and acetaminophen tablets. Educate patients and …

Adverse Reactions

openFDA Drug Labeling

ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of hydrocodone and acetaminophen tablets and Tablets. 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: Central Nervous System - Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychological dependence, mood changes. Gastrointestinal System- Constipation. Genitourinary System- Ureteral spasm, spasm of vesical sphincters, and urinary retention. Special Senses- Cases of Hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. Dermatological- Skin rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic reactions Hematological - Thrombocytopenia, agranulocytosis. 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 Tablets. • Androgen deficiency : Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY ]. DRUG ABUSE AND DEPENDENCE Controlled Substance Hydrocodone Bitartrate and Acetaminophen Tablets, USP contains hydrocodone, a Schedule II controlled substance. Abuse Hydrocodone Bitartrate and Acetaminophen Tablets, USP contains hydrocodone, a substance with a high potential for abuse similar to other opioids including. Hydrocodone Bitartrate and Acetaminophen Tablets, USP can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ]. All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “Drug seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction. Hydrocodone Bitartrate and Acetaminophen Tablets, USP, like other opioids, can be diverted for non-medical use into illicit c …

Drug Interactions

openFDA Drug Labeling

DRUG INTERACTIONS Inhibitors of CYP3A4 and CYP2D6 The concomitant use of hydrocodone bitartrate and acetaminophen tablets 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 the hydrocodone from hydrocodone bitartrate and acetaminophen tablets, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of hydrocodone bitartrate and acetaminophen tablets and both CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of hydrocodone bitartrate and acetaminophen tablets is achieved [see Warnings]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the 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 tablets. If concomitant use is necessary, consider dosage reduction of hydrocodone bitartrate and acetaminophen tablets 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 tablets dosage until stable drug effects are achieved. Evaluate for signs of opioid withdrawal. Inducers of CYP3A4 The concomitant use of hydrocodone bitartrate and acetaminophen tablets 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 hydrocodone [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 hydrocodone bitartrate and acetaminophen tablets dosage until stable drug effects are achieved. Evaluate the patient for signs and symptoms of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider hydrocodone bitartrate and acetaminophen tablets dosage reduction and evaluate patients at frequent intervals for signs of respiratory depression and sedation. Benzodiazepines and Other Central Nervous System (CNS) Depressants Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants, such as benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids, other opioids, 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, educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider prescribing an opioid overdose reversal agent [see Warnings]. 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), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatr …

Mechanism of Action

openFDA Drug Labeling

Mechanism of Action Hydrocodone is a full opioid agonist with relative selectivity for the mu-opioid (μ) receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of hydrocodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with hydrocodone. 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. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.

Description

openFDA Drug Labeling

DESCRIPTION Hydrocodone bitartrate and acetaminophen is available in tablet 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: Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 5 mg/300 mg contains: Hydrocodone Bitartrate. . . . . . . . 5 mg Acetaminophen. . . . . . . . . . . . . .300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/300 mg contains: Hydrocodone Bitartrate. . . . . . . . .7.5 mg Acetaminophen. . . . . . . . . . . . . . 300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/300 mg contains: Hydrocodone Bitartrate. . . . . . . . 10 mg Acetaminophen. . . . . . . . . . . . . .300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 5 mg/325 mg contains: Hydrocodone Bitartrate. . . . . . . . 5 mg Acetaminophen. . . . . . . . . . . . . .325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/325 mg contains: Hydrocodone Bitartrate. . . . . . . . .7.5 mg Acetaminophen. . . . . . . . . . . . . . 325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/325 mg contains: Hydrocodone Bitartrate. . . . . . . . 10 mg Acetaminophen. . . . . . . . . . . . . .325 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg: This product complies with USP dissolution test 2. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg: This product complies with USP dissolution test 1. hbt-chemical-structure apap-chemical-structure

OVERDOSAGE Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Clinical Presentation Acute overdose with hydrocodone bitartrate and acetaminophen tablets 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, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations. 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 techniques. The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to hydrocodone bitartrate and acetaminophen tablets overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to hydrocodone bitartrate and acetaminophen tablets overdose. Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone bitartrate and acetaminophen tablets in hydrocodone bitartrate and acetaminophen tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist 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 antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist. Acetaminophen Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion 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 the 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 early in the course of intoxication.

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Each tablet contains 5 mg of hydrocodone bitartrate and 325 mg of acetaminophen. They are available as white capsule-shaped tablets, bisected on one side and debossed on the other side with G 035. NDC 76420-875-01 Bottles of 1 (repackaged from NDC 27808-035-XX) NDC 76420-875-03 Bottles of 3 (repackaged from NDC 27808-035-XX) NDC 76420-875-07 Bottles of 7 (repackaged from NDC 27808-035-XX) NDC 76420-875-14 Bottles of 14 (repackaged from NDC 27808-035-XX) NDC 76420-875-20 Bottles of 20 (repackaged from NDC 27808-035-XX) NDC 76420-875-30 Bottles of 30 (repackaged from NDC 27808-035-XX) NDC 76420-875-60 Bottles of 60 (repackaged from NDC 27808-035-XX) NDC 76420-875-90 Bottles of 90 (repackaged from NDC 27808-035-XX) NDC 76420-875-10 Bottles of 100 (relabeled/repackaged from NDC 27808-035-01) NDC 76420-875-05 Bottles of 500 (relabeled/repackaged from NDC 27808-035-02) NDC 76420-875-00 Bottles of 1000 (relabeled/repackaged from NDC 27808-035-03) Each tablet contains 7.5 mg of hydrocodone bitartrate and 325 mg of acetaminophen. They are available as white capsule-shaped tablets, bisected on one side and debossed on the other side with G 036. NDC 76420-876-01 Bottles of 1 (repackaged from NDC 27808-036-XX) NDC 76420-876-03 Bottles of 3 (repackaged from NDC 27808-036-XX) NDC 76420-876-07 Bottles of 7 (repackaged from NDC 27808-036-XX) NDC 76420-876-14 Bottles of 14 (repackaged from NDC 27808-036-XX) NDC 76420-876-20 Bottles of 20 (repackaged from NDC 27808-036-XX) NDC 76420-876-30 Bottles of 30 (repackaged from NDC 27808-036-XX) NDC 76420-876-60 Bottles of 60 (repackaged from NDC 27808-036-XX) NDC 76420-876-90 Bottles of 90 (repackaged from NDC 27808-036-XX) NDC 76420-876-10 Bottles of 100 (relabeled/repackaged from NDC 27808-036-01) NDC 76420-876-05 Bottles of 500 (relabeled/repackaged from NDC 27808-036-02) NDC 76420-876-00 Bottles of 1000 (relabeled/repackaged from NDC 27808-036-03) Each tablet contains 10 mg of hydrocodone bitartrate and 325 mg of acetaminophen. They are available as white capsule-shaped tablets, bisected on one side and debossed on the other side with G 037. NDC 76420-877-01 Bottles of 1 (repackaged from NDC 27808-037-XX) NDC 76420-877-03 Bottles of 3 (repackaged from NDC 27808-037-XX) NDC 76420-877-07 Bottles of 7 (repackaged from NDC 27808-037-XX) NDC 76420-877-14 Bottles of 14 (repackaged from NDC 27808-037-XX) NDC 76420-877-20 Bottles of 20 (repackaged from NDC 27808-037-XX) NDC 76420-877-30 Bottles of 30 (repackaged from NDC 27808-037-XX) NDC 76420-877-60 Bottles of 60 (repackaged from NDC 27808-037-XX) NDC 76420-877-90 Bottles of 90 (repackaged from NDC 27808-037-XX) NDC 76420-877-10 Bottles of 100 (relabeled/repackaged from NDC 27808-037-01) NDC 76420-877-05 Bottles of 500 (relabeled/repackaged from NDC 27808-037-02) NDC 76420-877-00 Bottles of 1000 (relabeled/repackaged from NDC 27808-037-03) Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Store Hydrocodone Bitartrate and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS / Information for Patients ]. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Contains a Schedule II controlled drug substance. Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Adverse event reports

Source: openFDA FAERS
679,519
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ACETAMINOPHEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement
Drug recall enforcement reports associated with this product.
Classification Reported Firm Reason Status
Class II December 15, 2021 Ascent Pharmaceuticals, Inc. Product Mix-up Terminated
Class III June 6, 2018 LUPIN SOMERSET Labeling: Missing Label Terminated

Packaging and NDCs

Source: NDC Directory showing the first 400
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
50090-1778-0 50090-1778 A-S Medication Solutions 20 TABLET in 1 BOTTLE (50090-1778-0) April 14, 2015
50090-1778-7 50090-1778 A-S Medication Solutions 12 TABLET in 1 BOTTLE (50090-1778-7) January 29, 2019
60687-396-01 60687-396 American Health Packaging 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-396-01) / 1 TABLET in 1 BLISTER PACK (60687-396-11) June 27, 2023
60687-407-01 60687-407 American Health Packaging 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-407-01) / 1 TABLET in 1 BLISTER PACK (60687-407-11) April 15, 2019
60687-418-01 60687-418 American Health Packaging 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-418-01) / 1 TABLET in 1 BLISTER PACK (60687-418-11) April 15, 2019
65162-115-03 65162-115 Amneal Pharmaceuticals LLC 30 TABLET in 1 BOTTLE (65162-115-03) June 30, 2016
65162-115-10 65162-115 Amneal Pharmaceuticals LLC 100 TABLET in 1 BOTTLE (65162-115-10) June 30, 2016
65162-115-11 65162-115 Amneal Pharmaceuticals LLC 1000 TABLET in 1 BOTTLE (65162-115-11) June 30, 2016
65162-115-50 65162-115 Amneal Pharmaceuticals LLC 500 TABLET in 1 BOTTLE (65162-115-50) June 30, 2016
53746-109-01 53746-109 Amneal Pharmaceuticals of New York LLC 100 TABLET in 1 BOTTLE (53746-109-01) January 18, 2010
53746-109-05 53746-109 Amneal Pharmaceuticals of New York LLC 500 TABLET in 1 BOTTLE (53746-109-05) January 18, 2010
53746-109-10 53746-109 Amneal Pharmaceuticals of New York LLC 1000 TABLET in 1 BOTTLE (53746-109-10) January 18, 2010
53746-110-01 53746-110 Amneal Pharmaceuticals of New York LLC 100 TABLET in 1 BOTTLE (53746-110-01) February 18, 2010
53746-110-05 53746-110 Amneal Pharmaceuticals of New York LLC 500 TABLET in 1 BOTTLE (53746-110-05) February 18, 2010
53746-110-10 53746-110 Amneal Pharmaceuticals of New York LLC 1000 TABLET in 1 BOTTLE (53746-110-10) February 18, 2010
76420-133-01 76420-133 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (76420-133-01) November 10, 2025
76420-133-05 76420-133 Asclemed USA, Inc. 500 TABLET in 1 BOTTLE (76420-133-05) November 10, 2025
76420-133-30 76420-133 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (76420-133-30) December 16, 2020
76420-133-60 76420-133 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (76420-133-60) November 10, 2025
76420-133-90 76420-133 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (76420-133-90) November 10, 2025
76420-215-01 76420-215 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (76420-215-01) May 10, 2022
76420-215-30 76420-215 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (76420-215-30) May 10, 2022
76420-215-60 76420-215 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (76420-215-60) May 10, 2022
76420-215-90 76420-215 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (76420-215-90) May 10, 2022
76420-257-30 76420-257 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (76420-257-30) July 20, 2022
76420-257-60 76420-257 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (76420-257-60) July 20, 2022
76420-257-90 76420-257 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (76420-257-90) July 20, 2022
76420-875-00 76420-875 Asclemed USA, Inc. 1000 TABLET in 1 BOTTLE, PLASTIC (76420-875-00) November 12, 2024
76420-875-01 76420-875 Asclemed USA, Inc. 1 TABLET in 1 BOTTLE, PLASTIC (76420-875-01) November 12, 2024
76420-875-03 76420-875 Asclemed USA, Inc. 3 TABLET in 1 BOTTLE, PLASTIC (76420-875-03) November 12, 2024
76420-875-05 76420-875 Asclemed USA, Inc. 500 TABLET in 1 BOTTLE, PLASTIC (76420-875-05) November 12, 2024
76420-875-07 76420-875 Asclemed USA, Inc. 7 TABLET in 1 BOTTLE, PLASTIC (76420-875-07) November 12, 2024
76420-875-10 76420-875 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE, PLASTIC (76420-875-10) November 12, 2024
76420-875-14 76420-875 Asclemed USA, Inc. 14 TABLET in 1 BOTTLE, PLASTIC (76420-875-14) November 12, 2024
76420-875-20 76420-875 Asclemed USA, Inc. 20 TABLET in 1 BOTTLE, PLASTIC (76420-875-20) November 12, 2024
76420-875-30 76420-875 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE, PLASTIC (76420-875-30) November 12, 2024
76420-875-60 76420-875 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE, PLASTIC (76420-875-60) November 12, 2024
76420-875-90 76420-875 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE, PLASTIC (76420-875-90) November 12, 2024
76420-876-00 76420-876 Asclemed USA, Inc. 1000 TABLET in 1 BOTTLE, PLASTIC (76420-876-00) November 12, 2024
76420-876-01 76420-876 Asclemed USA, Inc. 1 TABLET in 1 BOTTLE, PLASTIC (76420-876-01) November 12, 2024
76420-876-03 76420-876 Asclemed USA, Inc. 3 TABLET in 1 BOTTLE, PLASTIC (76420-876-03) November 12, 2024
76420-876-05 76420-876 Asclemed USA, Inc. 500 TABLET in 1 BOTTLE, PLASTIC (76420-876-05) November 12, 2024
76420-876-07 76420-876 Asclemed USA, Inc. 7 TABLET in 1 BOTTLE, PLASTIC (76420-876-07) November 12, 2024
76420-876-10 76420-876 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE, PLASTIC (76420-876-10) November 12, 2024
76420-876-14 76420-876 Asclemed USA, Inc. 14 TABLET in 1 BOTTLE, PLASTIC (76420-876-14) November 12, 2024
76420-876-20 76420-876 Asclemed USA, Inc. 20 TABLET in 1 BOTTLE, PLASTIC (76420-876-20) November 12, 2024
76420-876-30 76420-876 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE, PLASTIC (76420-876-30) November 12, 2024
76420-876-60 76420-876 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE, PLASTIC (76420-876-60) November 12, 2024
76420-876-90 76420-876 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE, PLASTIC (76420-876-90) November 12, 2024
76420-877-00 76420-877 Asclemed USA, Inc. 1000 TABLET in 1 BOTTLE, PLASTIC (76420-877-00) November 12, 2024
76420-877-01 76420-877 Asclemed USA, Inc. 1 TABLET in 1 BOTTLE, PLASTIC (76420-877-01) November 12, 2024
76420-877-03 76420-877 Asclemed USA, Inc. 3 TABLET in 1 BOTTLE, PLASTIC (76420-877-03) November 12, 2024
76420-877-05 76420-877 Asclemed USA, Inc. 500 TABLET in 1 BOTTLE, PLASTIC (76420-877-05) November 12, 2024
76420-877-07 76420-877 Asclemed USA, Inc. 7 TABLET in 1 BOTTLE, PLASTIC (76420-877-07) November 12, 2024
76420-877-10 76420-877 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE, PLASTIC (76420-877-10) November 12, 2024
76420-877-14 76420-877 Asclemed USA, Inc. 14 TABLET in 1 BOTTLE, PLASTIC (76420-877-14) November 12, 2024
76420-877-20 76420-877 Asclemed USA, Inc. 20 TABLET in 1 BOTTLE, PLASTIC (76420-877-20) November 12, 2024
76420-877-30 76420-877 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE, PLASTIC (76420-877-30) November 12, 2024
76420-877-60 76420-877 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE, PLASTIC (76420-877-60) November 12, 2024
76420-877-90 76420-877 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE, PLASTIC (76420-877-90) November 12, 2024
87063-049-01 87063-049 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (87063-049-01) November 24, 2025
87063-049-05 87063-049 Asclemed USA, Inc. 5 TABLET in 1 BOTTLE (87063-049-05) November 24, 2025
87063-049-07 87063-049 Asclemed USA, Inc. 7 TABLET in 1 BOTTLE (87063-049-07) November 24, 2025
87063-049-10 87063-049 Asclemed USA, Inc. 10 TABLET in 1 BOTTLE (87063-049-10) November 24, 2025
87063-049-14 87063-049 Asclemed USA, Inc. 14 TABLET in 1 BOTTLE (87063-049-14) November 24, 2025
87063-049-20 87063-049 Asclemed USA, Inc. 20 TABLET in 1 BOTTLE (87063-049-20) November 24, 2025
87063-049-30 87063-049 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (87063-049-30) November 24, 2025
87063-049-60 87063-049 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (87063-049-60) November 24, 2025
87063-049-90 87063-049 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (87063-049-90) November 24, 2025
87063-050-01 87063-050 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (87063-050-01) November 24, 2025
87063-050-05 87063-050 Asclemed USA, Inc. 5 TABLET in 1 BOTTLE (87063-050-05) November 24, 2025
87063-050-07 87063-050 Asclemed USA, Inc. 7 TABLET in 1 BOTTLE (87063-050-07) November 24, 2025
87063-050-10 87063-050 Asclemed USA, Inc. 10 TABLET in 1 BOTTLE (87063-050-10) November 24, 2025
87063-050-14 87063-050 Asclemed USA, Inc. 14 TABLET in 1 BOTTLE (87063-050-14) November 24, 2025
87063-050-20 87063-050 Asclemed USA, Inc. 20 TABLET in 1 BOTTLE (87063-050-20) November 24, 2025
87063-050-30 87063-050 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (87063-050-30) November 24, 2025
87063-050-60 87063-050 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (87063-050-60) November 24, 2025
87063-050-90 87063-050 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (87063-050-90) November 24, 2025
87063-051-01 87063-051 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (87063-051-01) November 24, 2025
87063-051-05 87063-051 Asclemed USA, Inc. 5 TABLET in 1 BOTTLE (87063-051-05) November 24, 2025
87063-051-07 87063-051 Asclemed USA, Inc. 7 TABLET in 1 BOTTLE (87063-051-07) November 24, 2025
87063-051-10 87063-051 Asclemed USA, Inc. 10 TABLET in 1 BOTTLE (87063-051-10) November 24, 2025
87063-051-14 87063-051 Asclemed USA, Inc. 14 TABLET in 1 BOTTLE (87063-051-14) November 24, 2025
87063-051-20 87063-051 Asclemed USA, Inc. 20 TABLET in 1 BOTTLE (87063-051-20) November 24, 2025
87063-051-30 87063-051 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (87063-051-30) November 24, 2025
87063-051-60 87063-051 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (87063-051-60) November 24, 2025
87063-051-90 87063-051 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (87063-051-90) November 24, 2025
13107-019-01 13107-019 Aurolife Pharma, LLC 100 TABLET in 1 BOTTLE (13107-019-01) April 11, 2012
13107-019-05 13107-019 Aurolife Pharma, LLC 500 TABLET in 1 BOTTLE (13107-019-05) April 11, 2012
13107-019-30 13107-019 Aurolife Pharma, LLC 30 TABLET in 1 BOTTLE (13107-019-30) April 11, 2012
13107-019-99 13107-019 Aurolife Pharma, LLC 1000 TABLET in 1 BOTTLE (13107-019-99) April 11, 2012
13107-020-01 13107-020 Aurolife Pharma, LLC 100 TABLET in 1 BOTTLE (13107-020-01) April 11, 2012
13107-020-05 13107-020 Aurolife Pharma, LLC 500 TABLET in 1 BOTTLE (13107-020-05) April 11, 2012
13107-020-30 13107-020 Aurolife Pharma, LLC 30 TABLET in 1 BOTTLE (13107-020-30) April 11, 2012
13107-020-99 13107-020 Aurolife Pharma, LLC 1000 TABLET in 1 BOTTLE (13107-020-99) April 11, 2012
13107-021-01 13107-021 Aurolife Pharma, LLC 100 TABLET in 1 BOTTLE (13107-021-01) April 11, 2012
13107-021-05 13107-021 Aurolife Pharma, LLC 500 TABLET in 1 BOTTLE (13107-021-05) April 11, 2012
13107-021-30 13107-021 Aurolife Pharma, LLC 30 TABLET in 1 BOTTLE (13107-021-30) April 11, 2012
13107-021-99 13107-021 Aurolife Pharma, LLC 1000 TABLET in 1 BOTTLE (13107-021-99) April 11, 2012
13107-211-01 13107-211 Aurolife Pharma, LLC 100 TABLET in 1 BOTTLE (13107-211-01) May 6, 2015
13107-211-05 13107-211 Aurolife Pharma, LLC 500 TABLET in 1 BOTTLE (13107-211-05) May 6, 2015
13107-211-30 13107-211 Aurolife Pharma, LLC 30 TABLET in 1 BOTTLE (13107-211-30) May 6, 2015
13107-211-99 13107-211 Aurolife Pharma, LLC 1000 TABLET in 1 BOTTLE (13107-211-99) May 6, 2015
13107-212-01 13107-212 Aurolife Pharma, LLC 100 TABLET in 1 BOTTLE (13107-212-01) May 6, 2015
13107-212-05 13107-212 Aurolife Pharma, LLC 500 TABLET in 1 BOTTLE (13107-212-05) May 6, 2015
13107-212-30 13107-212 Aurolife Pharma, LLC 30 TABLET in 1 BOTTLE (13107-212-30) May 6, 2015
13107-212-99 13107-212 Aurolife Pharma, LLC 1000 TABLET in 1 BOTTLE (13107-212-99) May 6, 2015
13107-213-01 13107-213 Aurolife Pharma, LLC 100 TABLET in 1 BOTTLE (13107-213-01) May 6, 2015
13107-213-05 13107-213 Aurolife Pharma, LLC 500 TABLET in 1 BOTTLE (13107-213-05) May 6, 2015
13107-213-30 13107-213 Aurolife Pharma, LLC 30 TABLET in 1 BOTTLE (13107-213-30) May 6, 2015
13107-213-99 13107-213 Aurolife Pharma, LLC 1000 TABLET in 1 BOTTLE (13107-213-99) May 6, 2015
50268-400-15 50268-400 AvPAK 50 BLISTER PACK in 1 BOX (50268-400-15) / 1 TABLET in 1 BLISTER PACK (50268-400-11) October 28, 2016
50268-401-15 50268-401 AvPAK 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-401-15) / 1 TABLET in 1 BLISTER PACK (50268-401-11) September 15, 2014
50268-402-15 50268-402 AvPAK 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-402-15) / 1 TABLET in 1 BLISTER PACK (50268-402-11) September 15, 2014
63629-1177-1 63629-1177 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (63629-1177-1) June 17, 2019
63629-1179-1 63629-1179 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (63629-1179-1) September 1, 2020
63629-1180-1 63629-1180 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (63629-1180-1) November 9, 2022
63629-1181-1 63629-1181 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (63629-1181-1) September 1, 2020
63629-1183-1 63629-1183 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (63629-1183-1) November 9, 2022
63629-1184-1 63629-1184 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (63629-1184-1) September 1, 2020
63629-1938-1 63629-1938 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (63629-1938-1) July 13, 2018
63629-1939-1 63629-1939 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (63629-1939-1) July 13, 2018
63629-1940-1 63629-1940 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (63629-1940-1) July 13, 2018
63629-2292-1 63629-2292 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (63629-2292-1) October 6, 2014
63629-2293-1 63629-2293 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE, PLASTIC (63629-2293-1) October 6, 2014
63629-2294-1 63629-2294 Bryant Ranch Prepack 1000 TABLET in 1 BOTTLE, PLASTIC (63629-2294-1) October 6, 2014
63629-2295-1 63629-2295 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (63629-2295-1) October 6, 2014
63629-2296-1 63629-2296 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE, PLASTIC (63629-2296-1) October 6, 2014
63629-2297-1 63629-2297 Bryant Ranch Prepack 1000 TABLET in 1 BOTTLE, PLASTIC (63629-2297-1) October 6, 2014
63629-2298-1 63629-2298 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (63629-2298-1) October 6, 2014
63629-2299-1 63629-2299 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE, PLASTIC (63629-2299-1) October 6, 2014
63629-2300-1 63629-2300 Bryant Ranch Prepack 1000 TABLET in 1 BOTTLE, PLASTIC (63629-2300-1) October 6, 2014
63629-2308-1 63629-2308 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (63629-2308-1) April 7, 2016
63629-2309-1 63629-2309 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (63629-2309-1) April 7, 2016
63629-2310-1 63629-2310 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (63629-2310-1) April 7, 2016
63629-2468-1 63629-2468 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (63629-2468-1) April 12, 2016
63629-2469-1 63629-2469 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (63629-2469-1) April 12, 2016
63629-2470-1 63629-2470 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (63629-2470-1) April 12, 2016
63629-2471-1 63629-2471 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (63629-2471-1) April 12, 2016
63629-5422-0 63629-5422 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (63629-5422-0) July 25, 2017
63629-5422-1 63629-5422 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (63629-5422-1) October 6, 2014
63629-5422-2 63629-5422 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (63629-5422-2) October 14, 2014
63629-5422-3 63629-5422 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (63629-5422-3) October 6, 2014
63629-5422-4 63629-5422 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (63629-5422-4) October 6, 2014
63629-5422-5 63629-5422 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (63629-5422-5) October 6, 2014
63629-5422-6 63629-5422 Bryant Ranch Prepack 50 TABLET in 1 BOTTLE (63629-5422-6) December 22, 2019
63629-5422-7 63629-5422 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (63629-5422-7) October 23, 2014
63629-5422-8 63629-5422 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (63629-5422-8) November 3, 2014
63629-5422-9 63629-5422 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (63629-5422-9) December 1, 2014
63629-8499-1 63629-8499 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (63629-8499-1) April 12, 2016
63629-8885-1 63629-8885 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (63629-8885-1) October 7, 2021
63629-8885-2 63629-8885 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (63629-8885-2) October 7, 2021
63629-8885-3 63629-8885 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (63629-8885-3) October 26, 2021
63629-8885-4 63629-8885 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (63629-8885-4) September 5, 2024
63629-8885-5 63629-8885 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (63629-8885-5) October 26, 2021
63629-8886-1 63629-8886 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (63629-8886-1) October 6, 2021
63629-8886-2 63629-8886 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (63629-8886-2) September 5, 2024
63629-8886-3 63629-8886 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (63629-8886-3) October 6, 2021
63629-8886-4 63629-8886 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (63629-8886-4) October 7, 2021
63629-8886-5 63629-8886 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (63629-8886-5) October 13, 2021
71335-0108-0 71335-0108 Bryant Ranch Prepack 8 TABLET in 1 BOTTLE (71335-0108-0) December 12, 2018
71335-0108-1 71335-0108 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-0108-1) June 6, 2018
71335-0108-2 71335-0108 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-0108-2) December 11, 2018
71335-0108-3 71335-0108 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-0108-3) July 9, 2018
71335-0108-4 71335-0108 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-0108-4) September 4, 2019
71335-0108-5 71335-0108 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-0108-5) June 28, 2018
71335-0108-6 71335-0108 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-0108-6) May 30, 2018
71335-0108-7 71335-0108 Bryant Ranch Prepack 56 TABLET in 1 BOTTLE (71335-0108-7) October 8, 2024
71335-0108-8 71335-0108 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-0108-8) May 22, 2018
71335-0108-9 71335-0108 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-0108-9) May 31, 2018
71335-1271-0 71335-1271 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-1271-0) July 23, 2019
71335-1271-1 71335-1271 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-1271-1) November 6, 2019
71335-1271-2 71335-1271 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1271-2) July 23, 2019
71335-1271-3 71335-1271 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-1271-3) August 9, 2024
71335-1271-4 71335-1271 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-1271-4) August 9, 2024
71335-1271-5 71335-1271 Bryant Ranch Prepack 56 TABLET in 1 BOTTLE (71335-1271-5) August 9, 2024
71335-1271-6 71335-1271 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1271-6) July 18, 2019
71335-1271-7 71335-1271 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-1271-7) August 9, 2024
71335-1271-8 71335-1271 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1271-8) August 2, 2019
71335-1271-9 71335-1271 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-1271-9) August 9, 2024
71335-1339-1 71335-1339 Bryant Ranch Prepack 21 TABLET in 1 BOTTLE (71335-1339-1) September 11, 2019
71335-1339-2 71335-1339 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-1339-2) November 25, 2019
71335-1339-3 71335-1339 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-1339-3) October 21, 2019
71335-1417-0 71335-1417 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-1417-0) January 10, 2020
71335-1417-1 71335-1417 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1417-1) January 14, 2020
71335-1417-2 71335-1417 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-1417-2) October 2, 2020
71335-1417-3 71335-1417 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-1417-3) December 6, 2019
71335-1417-4 71335-1417 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1417-4) January 21, 2020
71335-1417-5 71335-1417 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1417-5) May 15, 2020
71335-1417-6 71335-1417 Bryant Ranch Prepack 8 TABLET in 1 BOTTLE (71335-1417-6) July 9, 2024
71335-1417-7 71335-1417 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-1417-7) May 18, 2020
71335-1417-8 71335-1417 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-1417-8) December 9, 2019
71335-1417-9 71335-1417 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-1417-9) July 9, 2024
71335-1418-0 71335-1418 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-1418-0) December 6, 2019
71335-1418-1 71335-1418 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-1418-1) February 13, 2020
71335-1418-2 71335-1418 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1418-2) December 6, 2019
71335-1418-3 71335-1418 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-1418-3) July 9, 2024
71335-1418-4 71335-1418 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-1418-4) July 9, 2024
71335-1418-5 71335-1418 Bryant Ranch Prepack 56 TABLET in 1 BOTTLE (71335-1418-5) July 9, 2024
71335-1418-6 71335-1418 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1418-6) December 9, 2019
71335-1418-7 71335-1418 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-1418-7) July 9, 2024
71335-1418-8 71335-1418 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1418-8) January 6, 2020
71335-1418-9 71335-1418 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-1418-9) July 9, 2024
71335-1419-0 71335-1419 Bryant Ranch Prepack 8 TABLET in 1 BOTTLE (71335-1419-0) May 12, 2020
71335-1419-1 71335-1419 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-1419-1) March 31, 2020
71335-1419-2 71335-1419 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-1419-2) July 6, 2020
71335-1419-3 71335-1419 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-1419-3) March 6, 2020
71335-1419-4 71335-1419 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-1419-4) July 9, 2024
71335-1419-5 71335-1419 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1419-5) February 20, 2020
71335-1419-6 71335-1419 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-1419-6) July 9, 2024
71335-1419-7 71335-1419 Bryant Ranch Prepack 56 TABLET in 1 BOTTLE (71335-1419-7) July 9, 2024
71335-1419-8 71335-1419 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1419-8) December 13, 2019
71335-1419-9 71335-1419 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1419-9) March 11, 2020
71335-1444-1 71335-1444 Bryant Ranch Prepack 21 TABLET in 1 BOTTLE (71335-1444-1) April 2, 2020
71335-1444-2 71335-1444 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-1444-2) June 15, 2020
71335-1444-3 71335-1444 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-1444-3) December 23, 2019
71335-1470-1 71335-1470 Bryant Ranch Prepack 21 TABLET in 1 BOTTLE (71335-1470-1) January 14, 2020
71335-1470-2 71335-1470 Bryant Ranch Prepack 12 TABLET in 1 BOTTLE (71335-1470-2) August 19, 2020
71335-1470-3 71335-1470 Bryant Ranch Prepack 18 TABLET in 1 BOTTLE (71335-1470-3) August 12, 2024
71335-1557-1 71335-1557 Bryant Ranch Prepack 21 TABLET in 1 BOTTLE (71335-1557-1) June 7, 2021
71335-1557-2 71335-1557 Bryant Ranch Prepack 36 TABLET in 1 BOTTLE (71335-1557-2) April 2, 2020
71335-1557-3 71335-1557 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-1557-3) May 13, 2026
71335-1811-1 71335-1811 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1811-1) August 12, 2024
71335-1811-2 71335-1811 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1811-2) August 12, 2024
71335-1811-3 71335-1811 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1811-3) August 12, 2024
71335-1811-4 71335-1811 Bryant Ranch Prepack 8 TABLET in 1 BOTTLE (71335-1811-4) March 19, 2021
71335-1811-5 71335-1811 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-1811-5) August 12, 2024
71335-1811-6 71335-1811 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-1811-6) August 12, 2024
71335-1970-1 71335-1970 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1970-1) October 7, 2021
71335-1970-2 71335-1970 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-1970-2) September 6, 2024
71335-1970-3 71335-1970 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-1970-3) September 6, 2024
71335-1970-4 71335-1970 Bryant Ranch Prepack 56 TABLET in 1 BOTTLE (71335-1970-4) September 6, 2024
71335-1970-5 71335-1970 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1970-5) October 7, 2021
71335-1970-6 71335-1970 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1970-6) October 26, 2021
71335-1970-7 71335-1970 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-1970-7) October 26, 2021
71335-2103-1 71335-2103 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2103-1) June 6, 2022
71335-2103-2 71335-2103 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2103-2) June 6, 2022
71335-2103-3 71335-2103 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2103-3) June 6, 2022
71335-2103-4 71335-2103 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-2103-4) June 6, 2022
71335-2103-5 71335-2103 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-2103-5) June 6, 2022
71335-2104-1 71335-2104 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2104-1) June 6, 2022
71335-2104-2 71335-2104 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-2104-2) June 6, 2022
71335-2104-3 71335-2104 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-2104-3) June 6, 2022
71335-2104-4 71335-2104 Bryant Ranch Prepack 56 TABLET in 1 BOTTLE (71335-2104-4) June 6, 2022
71335-2104-5 71335-2104 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2104-5) June 6, 2022
71335-2104-6 71335-2104 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2104-6) June 6, 2022
71335-2104-7 71335-2104 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-2104-7) June 6, 2022
71335-2105-1 71335-2105 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2105-1) June 6, 2022
71335-2105-2 71335-2105 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-2105-2) June 6, 2022
71335-2105-3 71335-2105 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2105-3) June 6, 2022
71335-2105-4 71335-2105 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2105-4) June 6, 2022
71335-2105-5 71335-2105 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-2105-5) June 6, 2022
71335-2112-1 71335-2112 Bryant Ranch Prepack 21 TABLET in 1 BOTTLE (71335-2112-1) June 20, 2022
71335-2112-2 71335-2112 Bryant Ranch Prepack 36 TABLET in 1 BOTTLE (71335-2112-2) June 20, 2022
71335-2112-3 71335-2112 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-2112-3) June 20, 2022
71335-2115-0 71335-2115 Bryant Ranch Prepack 8 TABLET in 1 BOTTLE (71335-2115-0) June 20, 2022
71335-2115-1 71335-2115 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-2115-1) June 20, 2022
71335-2115-2 71335-2115 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-2115-2) June 20, 2022
71335-2115-3 71335-2115 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-2115-3) June 20, 2022
71335-2115-4 71335-2115 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-2115-4) June 20, 2022
71335-2115-5 71335-2115 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2115-5) June 20, 2022
71335-2115-6 71335-2115 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-2115-6) June 20, 2022
71335-2115-7 71335-2115 Bryant Ranch Prepack 56 TABLET in 1 BOTTLE (71335-2115-7) June 20, 2022
71335-2115-8 71335-2115 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2115-8) June 20, 2022
71335-2115-9 71335-2115 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2115-9) June 20, 2022
71335-2116-1 71335-2116 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2116-1) September 6, 2024
71335-2116-2 71335-2116 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2116-2) September 6, 2024
71335-2116-3 71335-2116 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2116-3) September 6, 2024
71335-2116-4 71335-2116 Bryant Ranch Prepack 8 TABLET in 1 BOTTLE (71335-2116-4) June 13, 2022
71335-2116-5 71335-2116 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-2116-5) September 6, 2024
71335-2117-0 71335-2117 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-2117-0) June 20, 2022
71335-2117-1 71335-2117 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2117-1) June 20, 2022
71335-2117-2 71335-2117 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-2117-2) June 20, 2022
71335-2117-3 71335-2117 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-2117-3) June 20, 2022
71335-2117-4 71335-2117 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2117-4) June 20, 2022
71335-2117-5 71335-2117 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2117-5) June 20, 2022
71335-2117-6 71335-2117 Bryant Ranch Prepack 50 TABLET in 1 BOTTLE (71335-2117-6) June 20, 2022
71335-2117-7 71335-2117 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-2117-7) June 20, 2022
71335-2117-8 71335-2117 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-2117-8) June 20, 2022
71335-2117-9 71335-2117 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-2117-9) June 20, 2022
71335-2118-0 71335-2118 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-2118-0) June 20, 2022
71335-2118-1 71335-2118 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-2118-1) June 20, 2022
71335-2118-2 71335-2118 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2118-2) June 20, 2022
71335-2118-3 71335-2118 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-2118-3) June 20, 2022
71335-2118-4 71335-2118 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-2118-4) June 20, 2022
71335-2118-5 71335-2118 Bryant Ranch Prepack 56 TABLET in 1 BOTTLE (71335-2118-5) June 20, 2022
71335-2118-6 71335-2118 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2118-6) June 20, 2022
71335-2118-7 71335-2118 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-2118-7) June 20, 2022
71335-2118-8 71335-2118 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2118-8) June 20, 2022
71335-2118-9 71335-2118 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-2118-9) June 20, 2022
71335-2144-0 71335-2144 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-2144-0) August 1, 2022
71335-2144-1 71335-2144 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2144-1) September 6, 2024
71335-2144-2 71335-2144 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-2144-2) September 6, 2024
71335-2144-3 71335-2144 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-2144-3) August 1, 2022
71335-2144-4 71335-2144 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2144-4) September 6, 2024
71335-2144-5 71335-2144 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2144-5) September 6, 2024
71335-2144-6 71335-2144 Bryant Ranch Prepack 50 TABLET in 1 BOTTLE (71335-2144-6) September 6, 2024
71335-2144-7 71335-2144 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-2144-7) September 6, 2024
71335-2144-8 71335-2144 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-2144-8) September 6, 2024
71335-2144-9 71335-2144 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-2144-9) September 6, 2024
71335-2195-1 71335-2195 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2195-1) December 1, 2022
71335-2195-2 71335-2195 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2195-2) December 1, 2022
71335-2195-3 71335-2195 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2195-3) December 1, 2022
71335-2195-4 71335-2195 Bryant Ranch Prepack 8 TABLET in 1 BOTTLE (71335-2195-4) December 1, 2022
71335-2195-5 71335-2195 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-2195-5) December 1, 2022
71335-2195-6 71335-2195 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-2195-6) December 1, 2022
71335-2238-1 71335-2238 Bryant Ranch Prepack 21 TABLET in 1 BOTTLE, PLASTIC (71335-2238-1) May 28, 2024
71335-2238-2 71335-2238 Bryant Ranch Prepack 36 TABLET in 1 BOTTLE, PLASTIC (71335-2238-2) May 28, 2024
71335-2238-3 71335-2238 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE, PLASTIC (71335-2238-3) May 28, 2024
71335-2585-1 71335-2585 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2585-1) April 3, 2025
71335-2585-2 71335-2585 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2585-2) April 3, 2025
71335-2585-3 71335-2585 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2585-3) April 3, 2025
71335-2585-4 71335-2585 Bryant Ranch Prepack 8 TABLET in 1 BOTTLE (71335-2585-4) April 3, 2025
71335-2585-5 71335-2585 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-2585-5) April 3, 2025
71335-2585-6 71335-2585 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-2585-6) April 3, 2025
71335-2740-1 71335-2740 Bryant Ranch Prepack 1000 TABLET in 1 BOTTLE (71335-2740-1) July 29, 2025
71335-2969-1 71335-2969 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-2969-1) October 23, 2025
71335-9602-1 71335-9602 Bryant Ranch Prepack 21 TABLET in 1 BOTTLE (71335-9602-1) December 12, 2022
71335-9602-2 71335-9602 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE (71335-9602-2) December 12, 2022
71335-9602-3 71335-9602 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-9602-3) December 12, 2022
71335-9734-0 71335-9734 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE, PLASTIC (71335-9734-0) June 8, 2023
71335-9734-1 71335-9734 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE, PLASTIC (71335-9734-1) May 15, 2023
71335-9734-2 71335-9734 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE, PLASTIC (71335-9734-2) May 30, 2023
71335-9734-3 71335-9734 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE, PLASTIC (71335-9734-3) May 30, 2023
71335-9734-4 71335-9734 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE, PLASTIC (71335-9734-4) June 2, 2023
71335-9734-5 71335-9734 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE, PLASTIC (71335-9734-5) October 18, 2023
71335-9734-6 71335-9734 Bryant Ranch Prepack 50 TABLET in 1 BOTTLE, PLASTIC (71335-9734-6) April 9, 2026
71335-9734-7 71335-9734 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE, PLASTIC (71335-9734-7) October 17, 2023
71335-9734-8 71335-9734 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE, PLASTIC (71335-9734-8) May 30, 2023
71335-9734-9 71335-9734 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE, PLASTIC (71335-9734-9) April 9, 2026
71335-9735-0 71335-9735 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE, PLASTIC (71335-9735-0) May 30, 2023
71335-9735-1 71335-9735 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE, PLASTIC (71335-9735-1) May 30, 2023
71335-9735-2 71335-9735 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE, PLASTIC (71335-9735-2) May 30, 2023
71335-9735-3 71335-9735 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE, PLASTIC (71335-9735-3) April 9, 2026
71335-9735-4 71335-9735 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE, PLASTIC (71335-9735-4) April 9, 2026
71335-9735-5 71335-9735 Bryant Ranch Prepack 56 TABLET in 1 BOTTLE, PLASTIC (71335-9735-5) April 9, 2026
71335-9735-6 71335-9735 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE, PLASTIC (71335-9735-6) May 8, 2023
71335-9735-7 71335-9735 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE, PLASTIC (71335-9735-7) April 9, 2026
71335-9735-8 71335-9735 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE, PLASTIC (71335-9735-8) July 5, 2023
71335-9735-9 71335-9735 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (71335-9735-9) April 9, 2026
71335-9736-0 71335-9736 Bryant Ranch Prepack 8 TABLET in 1 BOTTLE, PLASTIC (71335-9736-0) April 9, 2026
71335-9736-1 71335-9736 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE, PLASTIC (71335-9736-1) November 28, 2023
71335-9736-2 71335-9736 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE, PLASTIC (71335-9736-2) October 17, 2023
71335-9736-3 71335-9736 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE, PLASTIC (71335-9736-3) June 28, 2023
71335-9736-4 71335-9736 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE, PLASTIC (71335-9736-4) April 9, 2026
71335-9736-5 71335-9736 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE, PLASTIC (71335-9736-5) September 6, 2023
71335-9736-6 71335-9736 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE, PLASTIC (71335-9736-6) April 9, 2026
71335-9736-7 71335-9736 Bryant Ranch Prepack 56 TABLET in 1 BOTTLE, PLASTIC (71335-9736-7) April 9, 2026
71335-9736-8 71335-9736 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE, PLASTIC (71335-9736-8) December 5, 2023
71335-9736-9 71335-9736 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE, PLASTIC (71335-9736-9) December 15, 2023
71335-9737-1 71335-9737 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE, PLASTIC (71335-9737-1) April 9, 2026
71335-9737-2 71335-9737 Bryant Ranch Prepack 15 TABLET in 1 BOTTLE, PLASTIC (71335-9737-2) April 9, 2026
71335-9737-3 71335-9737 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE, PLASTIC (71335-9737-3) April 9, 2026
71335-9737-4 71335-9737 Bryant Ranch Prepack 56 TABLET in 1 BOTTLE, PLASTIC (71335-9737-4) April 9, 2026
71335-9737-5 71335-9737 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE, PLASTIC (71335-9737-5) June 14, 2023
71335-9737-6 71335-9737 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE, PLASTIC (71335-9737-6) April 9, 2026
71335-9737-7 71335-9737 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE, PLASTIC (71335-9737-7) April 9, 2026
72162-1279-0 72162-1279 Bryant Ranch Prepack 1000 TABLET in 1 BOTTLE, PLASTIC (72162-1279-0) October 6, 2014
72162-1279-1 72162-1279 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (72162-1279-1) October 6, 2014
72162-1279-5 72162-1279 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE, PLASTIC (72162-1279-5) October 6, 2014
72162-1280-0 72162-1280 Bryant Ranch Prepack 1000 TABLET in 1 BOTTLE, PLASTIC (72162-1280-0) October 6, 2014
72162-1280-1 72162-1280 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (72162-1280-1) October 6, 2014
72162-1280-5 72162-1280 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE, PLASTIC (72162-1280-5) October 6, 2014
72162-1280-6 72162-1280 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE, PLASTIC (72162-1280-6) October 6, 2014
72162-1281-0 72162-1281 Bryant Ranch Prepack 1000 TABLET in 1 BOTTLE, PLASTIC (72162-1281-0) October 6, 2014
72162-1281-1 72162-1281 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (72162-1281-1) October 6, 2014
72162-1281-5 72162-1281 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE, PLASTIC (72162-1281-5) October 6, 2014
72162-1287-1 72162-1287 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (72162-1287-1) April 7, 2016
72162-1288-1 72162-1288 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (72162-1288-1) April 7, 2016
72162-1289-1 72162-1289 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (72162-1289-1) April 7, 2016
72162-1341-1 72162-1341 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (72162-1341-1) April 12, 2016
72162-1341-5 72162-1341 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (72162-1341-5) April 12, 2016
72162-1342-1 72162-1342 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (72162-1342-1) April 12, 2016
72162-1989-1 72162-1989 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (72162-1989-1) July 13, 2018
72162-1990-5 72162-1990 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (72162-1990-5) July 13, 2018
72162-1991-1 72162-1991 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (72162-1991-1) July 13, 2018
72162-1996-1 72162-1996 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (72162-1996-1) June 17, 2019
72162-1996-5 72162-1996 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (72162-1996-5) June 17, 2019
72162-1997-1 72162-1997 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (72162-1997-1) June 17, 2019
72162-1997-5 72162-1997 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (72162-1997-5) June 17, 2019
72162-1998-1 72162-1998 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (72162-1998-1) June 17, 2019
72162-1998-5 72162-1998 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (72162-1998-5) June 17, 2019
72162-2271-1 72162-2271 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (72162-2271-1) April 12, 2016
72162-2271-5 72162-2271 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE (72162-2271-5) April 12, 2016
31722-940-01 31722-940 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-940-01) August 22, 2025
31722-942-01 31722-942 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-942-01) August 22, 2025
31722-942-05 31722-942 Camber Pharmaceuticals, Inc. 500 TABLET in 1 BOTTLE (31722-942-05) August 22, 2025
31722-996-01 31722-996 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-996-01) November 8, 2018
31722-996-05 31722-996 Camber Pharmaceuticals, Inc. 500 TABLET in 1 BOTTLE (31722-996-05) November 8, 2018
31722-997-01 31722-997 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-997-01) November 8, 2018
31722-997-05 31722-997 Camber Pharmaceuticals, Inc. 500 TABLET in 1 BOTTLE (31722-997-05) November 8, 2018
27808-035-01 27808-035 Cranbury Pharmaceuticals, LLC 100 TABLET in 1 BOTTLE, PLASTIC (27808-035-01) October 6, 2014
27808-035-02 27808-035 Cranbury Pharmaceuticals, LLC 500 TABLET in 1 BOTTLE, PLASTIC (27808-035-02) October 6, 2014
27808-035-03 27808-035 Cranbury Pharmaceuticals, LLC 1000 TABLET in 1 BOTTLE, PLASTIC (27808-035-03) October 6, 2014
27808-036-01 27808-036 Cranbury Pharmaceuticals, LLC 100 TABLET in 1 BOTTLE, PLASTIC (27808-036-01) October 6, 2014
27808-036-02 27808-036 Cranbury Pharmaceuticals, LLC 500 TABLET in 1 BOTTLE, PLASTIC (27808-036-02) October 6, 2014
27808-036-03 27808-036 Cranbury Pharmaceuticals, LLC 1000 TABLET in 1 BOTTLE, PLASTIC (27808-036-03) October 6, 2014
27808-037-01 27808-037 Cranbury Pharmaceuticals, LLC 100 TABLET in 1 BOTTLE, PLASTIC (27808-037-01) October 6, 2014
27808-037-02 27808-037 Cranbury Pharmaceuticals, LLC 500 TABLET in 1 BOTTLE, PLASTIC (27808-037-02) October 6, 2014
27808-037-03 27808-037 Cranbury Pharmaceuticals, LLC 1000 TABLET in 1 BOTTLE, PLASTIC (27808-037-03) October 6, 2014

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts
Enforcement FDA Recall records

Generated September 25, 2026 · 13 sections on this page.