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Oxycodone 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
Oxycodone and Acetaminophen
Generic name
Oxycodone 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
10
NDC product codes
110
Packages
409
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
Oxycodone 10 mg/1 1049214 View
Oxycodone 2.5 mg/1 1049214 View
Oxycodone 5 mg/1 1049214 View
Oxycodone 7.5 mg/1 1049214 View
Oxycodone Hydrochloride 10 mg/1 1049621 View
Oxycodone Hydrochloride 2.5 mg/1 1049621 View
Oxycodone Hydrochloride 5 mg/1 1049621 View
Oxycodone Hydrochloride 7.5 mg/1 1049621 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
Full Opioid Agonists [MoA] MoA All 74 members
Opioid Agonist [EPC] EPC All 109 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207419
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 22, 2017
Sponsor
ASCENT PHARMS INC
Products on application
4
Submissions recorded
13
Products approved under application 207419.
Product Trade name Form Strength Ingredient Status TE Flags
207419-001 OXYCODONE AND ACETAMINOPHEN TABLET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Prescription AA
207419-002 OXYCODONE AND ACETAMINOPHEN TABLET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Prescription AA
207419-003 OXYCODONE AND ACETAMINOPHEN TABLET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE Prescription AA
207419-004 OXYCODONE AND ACETAMINOPHEN TABLET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 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 207419.
Type No. Action Status Date Review
Supplement 21 REMS Approved June 18, 2026 —
Supplement 20 Labeling Approved December 22, 2025 Standard
Supplement 14 REMS Approved October 31, 2024 —
Supplement 15 Labeling Approved August 22, 2024 Standard
Supplement 13 Labeling Approved August 22, 2024 Standard
Supplement 12 Labeling Approved December 15, 2023 Standard
Supplement 11 Labeling Approved December 15, 2023 Standard
Supplement 10 Labeling Approved March 4, 2021 Standard
Supplement 6 Labeling Approved October 7, 2019 Standard
Supplement 3 Manufacturing (CMC) Approved October 29, 2018 Unknown
Supplement 4 Labeling Approved September 20, 2018 Standard
Supplement 2 REMS Approved September 18, 2018 —
Original application 1 Approved March 22, 2017 Standard

Review documents

  • 0 · Original application · November 8, 2023

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260615). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20260615 HUMAN PRESCRIPTION DRUG · 20251201 HUMAN PRESCRIPTION DRUG · 20251130 HUMAN PRESCRIPTION DRUG · 20250415

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 Oxycodone and acetaminophen tablets expose 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 oxycodone and acetaminophen tablets, and monitor all patients regularly for the development of these behaviors and 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 oxycodone and acetaminophen tablets. Monitor for respiratory depression, especially during initiation of oxycodone and acetaminophen tablets or following a dose increase [see WARNINGS ]. Accidental Ingestion Accidental ingestion of oxycodone and acetaminophen tablets, especially by children, can result in fatal overdose of oxycodone and acetaminophen tablets [see WARNINGS ]. Neonatal Opioid Withdrawal Syndrome Prolonged use of oxycodone 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 oxycodone and acetaminophen tablets with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone 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 oxycodone plasma concentration. Monitor patients receiving oxycodone and acetaminophen tablets and any CYP3A4 inhibitor or inducer [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 mg per day, and often involve more than one acetaminophen-containing product. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS , PRECAUTIONS; Drug Interactions ]. Reserve concomitant prescribing of oxycodone and acetaminophen tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options …

Indications and Usage

openFDA Drug Labeling

INDICATIONS AND USAGE Oxycodone 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 oxycodone 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 Oxycodone 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 Oxycodone 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 oxycodone 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 oxycodone 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 Oxycodone and Acetaminophen Tablets as the First Opioid Analgesic Initiate treatment with oxycodone and acetaminophen tablets using oxycodone and acetaminophen tablets 2.5 mg/325 mg tablets in a dosing range of 1 to 2 tablets every 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 oxycodone and acetaminophen tablets. The total daily dose of acetaminophen should not exceed 4 grams. Strength Usual Adult Dosage Maximal Daily Dose Oxycodone and Acetaminophen Tablets 5 mg/325 mg 1 tablet every 6 hours as needed for pain 12 Tablets Oxycodone and Acetaminophen Tablets 7.5 mg/325 mg 1 tablet every 6 hours as needed for pain 8 Tablets Oxycodone and Acetaminophen Tablets 10 mg/325 mg 1 tablet every 6 hours as needed for pain 6 Tablets Conversion from Oxycodone and Acetaminophen Tablets to Extended-Release Oxycodone The relative bioavailability of oxycodone and acetaminophen tablets compared to extended-release oxycodo …

Contraindications

openFDA Drug Labeling

CONTRAINDICATIONS Oxycodone and acetaminophen tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus.

WARNINGS Addiction, Abuse, and Misuse Oxycodone and acetaminophen tablets contain oxycodone, a Schedule II controlled substance. As an opioid, oxycodone 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 patients appropriately prescribed oxycodone and acetaminophen tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing oxycodone and acetaminophen tablets, and monitor all patients receiving oxycodone 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 oxycodone and acetaminophen tablets, but use in such patients necessitates intensive counseling about the risks and proper use of oxycodone and acetaminophen tablets along with intensive monitoring for signs of addiction, abuse, and misuse. Consider prescribing naloxone for the emergency treatment of opioid overdose [see WARNINGS, Life-Threatening Respiratory Depression ; DOSAGE AND ADMINISTRATION, Patient Access to Naloxone for The Emergency Treatment of Opioid Overdose ] . Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing oxycodone and acetaminophen tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see PRECAUTIONS; Information for Patients/Caregivers ]. 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. 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 Risk Evaluation and Mitigation Strategy (REMS) for these products. 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 do all of the following: Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) or another education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain. Discuss the safe use, serious risks, and proper storage and disposal of opioid analgesics with patients and/or their caregivers every time these medicines are prescribed. The Patient Counseling Guide (PCG) can be obtained at this link: www.fda.gov/OpioidAnalgesicREMSPCG . Emphasize to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an opioid analgesic is dispensed to them. Consider using other tools to improve patient, household, and community safety, such as patient-prescriber agreements that reinforce patient-prescriber responsibilities. To obtain further information on the opioid analgesic REMS and for a list of accredited REMS CME/CE, call 1-800-503-0784, or log on to www.opioidanalgesicrems.com . The FDA Blueprint can be found at www.fda.gov/OpioidAnalgesicREMSBlueprint . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even …

Adverse Reactions

openFDA Drug Labeling

ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of oxycodone and acetaminophen 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. Serious adverse reactions that may be associated with oxycodone and acetaminophen use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock [see OVERDOSAGE ] . The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation, and pruritus. Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has likewise been associated with acetaminophen use. In high doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma also may occur. Other adverse reactions obtained from postmarketing experiences with oxycodone and acetaminophen are listed by organ system and in decreasing order of severity and/or frequency as follows: Body as a Whole: Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest pain, fever, hypothermia, thirst, headache, increased sweating, accidental overdose, non-accidental overdose Cardiovascular: Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias Central and Peripheral Nervous System: Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental impairment, agitation, cerebral edema, confusion, dizziness Fluid and Electrolyte: Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis Gastrointestinal: Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry mouth, flatulence, gastrointestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus Hepatic: Transient elevations of hepatic enzymes, increase in bilirubin, hepatitis, hepatic failure, jaundice, hepatotoxicity, hepatic disorder Hearing and Vestibular: Hearing loss, tinnitus Hematologic: Thrombocytopenia Hypersensitivity: Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction Metabolic and Nutritional: Hypoglycemia, hyperglycemia, acidosis, alkalosis Musculoskeletal: Myalgia, rhabdomyolysis Ocular: Miosis, visual disturbances, red eye Psychiatric: Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of consciousness, nervousness, hallucination, somnolence, depression, suicide Respiratory System: Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal edema Skin and Appendages: Erythema, urticaria, rash, flushing Urogenital: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Anaphylaxis : Anaphylaxis has been reported with ingredients contained in oxycodone and acetaminophen tablets. Androgen deficiency : Cases of androgen deficiency have occurred with use of opioids for an extended period of time. Hyperalgesia and Allodynia : Cases of hyperalgesia and allodynia have been rep …

Drug Interactions

openFDA Drug Labeling

DRUG INTERACTIONS Inhibitors of CYP3A4 and CYP2D6 The concomitant use of Oxycodone 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 oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Oxycodone and Acetaminophen Tablets and CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of Oxycodone and Acetaminophen Tablets are achieved [see Warnings]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see Clinical Pharmacology] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Oxycodone and Acetaminophen Tablets. If concomitant use is necessary, consider dosage reduction of Oxycodone 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 Oxycodone and Acetaminophen Tablets dosage until stable drug effects are achieved. Evaluate for signs of opioid withdrawal. Inducers of CYP3A4 The concomitant use of Oxycodone and Acetaminophen Tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of oxycodone [see Clinical Pharmacology] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to Oxycodone and Acetaminophen Tablets [see Warnings]. After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone 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 Oxycodone and Acetaminophen Tablets dosage until stable drug effects are achieved. Evaluate for sign of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Oxycodone 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 sedative hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including 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 naloxone for the emergency treatment of opioid overdose [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), tryptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome. [see Precautions; Information for Patients/ …

Mechanism of Action

openFDA Drug Labeling

Mechanism of Action Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.

Description

openFDA Drug Labeling

DESCRIPTION Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration. Each tablet for oral administration, contains Oxycodone Hydrochloride and Acetaminophen in the following strengths: Oxycodone Hydrochloride, USP.................................................................. 2.5 mg* (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg of Oxycodone) Acetaminophen, USP...................................................................................... 325 mg Oxycodone Hydrochloride, USP.................................................................. 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg of Oxycodone) Acetaminophen, USP...................................................................................... 325 mg Oxycodone Hydrochloride, USP.................................................................. 7.5 mg* (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg of Oxycodone) Acetaminophen, USP...................................................................................... 325 mg Oxycodone Hydrochloride, USP.................................................................. 10 mg* (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg of Oxycodone) Acetaminophen, USP...................................................................................... 325 mg All Strengths of Oxycodone and Acetaminophen Tablets also contains the following inactive ingredients: Colloidal silicon dioxide, povidone, cross-linked povidone, corn starch, pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, and stearic acid. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18 H 21 NO 4 ∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula: C 18 H 21 NO 4 ·HCl MW 351.82 Oxycodone and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, free flowing granules. The molecular formula for acetaminophen is C 8 H 9 NO 2 and the molecular weight is 151.16. It may be represented by the following structural formula: C 8 H 9 NO 2 MW 151.16 oxy-structure apap-structure

OVERDOSAGE Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen. Clinical Presentation Oxycodone Acute overdosage with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [ see CLINCAL 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 Oxycodone In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone in oxycodone and acetaminophen tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent 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 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 antagonist reversal agent administered. If a decision is made to treat serious respiratory depression in the physically-dependent patient, administration of the antagonist reversal agent should be initiated begin with care and by titration with smaller than usual doses of the antagonist reversal agent. 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 Oxycodone and Acetaminophen Tablets, USP are supplied as follows: 2.5 mg/325 mg White to Off-white color capsule shaped tablets debossed with ‘T 191’ on one side and plain on other side. Bottles of 30 NDC 76420-320-30 (repackaged from NDC 31722-948-XX) Bottles of 60 NDC 76420-320-60 (repackaged from NDC 31722-948-XX) Bottles of 90 NDC 76420-320-90 (repackaged from NDC 31722-948-XX) Bottles of 100 NDC 76420-320-01 (relabeled from NDC 31722-948-01) Bottles of 500 NDC 76420-320-05 (relabeled from NDC 31722-948-05) 5 mg/325 mg White to off-white color round, biconvex tablets having break line on one side and debossed with ‘T 192’ on other side. Bottles of 30 NDC 76420-321-30 (repackaged from NDC 31722-949-XX) Bottles of 60 NDC 76420-321-60 (repackaged from NDC 31722-949-XX) Bottles of 90 NDC 76420-321-90 (repackaged from NDC 31722-949-XX) Bottles of 100 NDC 76420-321-01 (relabeled from NDC 31722-949-01) Bottles of 500 NDC 76420-321-05 (relabeled from NDC 31722-949-05) 7.5 mg/325 mg White to Off-white color capsule shaped tablets debossed with ‘T 193’ on one side and plain on other side. Bottles of 30 NDC 76420-322-30 (repackaged from NDC 31722-950-XX) Bottles of 60 NDC 76420-322-60 (repackaged from NDC 31722-950-XX) Bottles of 90 NDC 76420-322-90 (repackaged from NDC 31722-950-XX) Bottles of 100 NDC 76420-322-01 (relabeled from NDC 31722-950-01) Bottles of 500 NDC 76420-322-05 (relabeled from NDC 31722-950-05) 10 mg/325 mg White to off-white color capsule shaped tablets debossed with ‘T 194’ on one side and plain on other side. Bottles of 30 NDC 76420-323-30 (repackaged from NDC 31722-951-XX) Bottles of 60 NDC 76420-323-60 (repackaged from NDC 31722-951-XX) Bottles of 90 NDC 76420-323-90 (repackaged from NDC 31722-951-XX) Bottles of 100 NDC 76420-323-01 (relabeled from NDC 31722-951-01) Bottles of 500 NDC 76420-323-05 (relabeled from NDC 31722-951-05) Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [see Precautions/Information for Patients]. 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 January 14, 2026 SpecGx, LLC Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. Ongoing
Class II January 14, 2026 SpecGx, LLC Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. Ongoing
Class II April 22, 2020 Aurobindo Pharma USA Inc. CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed 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
47781-196-01 47781-196 Alvogen, Inc. 100 TABLET in 1 BOTTLE (47781-196-01) March 9, 2016
47781-196-05 47781-196 Alvogen, Inc. 500 TABLET in 1 BOTTLE (47781-196-05) March 9, 2016
47781-229-01 47781-229 Alvogen, Inc. 100 TABLET in 1 BOTTLE (47781-229-01) January 17, 2012
47781-229-05 47781-229 Alvogen, Inc. 500 TABLET in 1 BOTTLE (47781-229-05) January 17, 2012
47781-230-01 47781-230 Alvogen, Inc. 100 TABLET in 1 BOTTLE (47781-230-01) January 17, 2012
47781-230-05 47781-230 Alvogen, Inc. 500 TABLET in 1 BOTTLE (47781-230-05) January 17, 2012
47781-230-63 47781-230 Alvogen, Inc. 250 TABLET in 1 BOTTLE (47781-230-63) January 17, 2012
60687-642-01 60687-642 American Health Packaging 100 BLISTER PACK in 1 CARTON (60687-642-01) / 1 TABLET in 1 BLISTER PACK (60687-642-11) January 4, 2022
68084-699-01 68084-699 American Health Packaging 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-699-01) / 1 TABLET in 1 BLISTER PACK (68084-699-11) June 6, 2014
68084-710-01 68084-710 American Health Packaging 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-710-01) / 1 TABLET in 1 BLISTER PACK (68084-710-11) June 4, 2014
65162-207-03 65162-207 Amneal Pharmaceuticals LLC 30 TABLET in 1 BOTTLE (65162-207-03) November 1, 2013
65162-207-10 65162-207 Amneal Pharmaceuticals LLC 100 TABLET in 1 BOTTLE (65162-207-10) November 1, 2013
65162-207-50 65162-207 Amneal Pharmaceuticals LLC 500 TABLET in 1 BOTTLE (65162-207-50) November 1, 2013
53746-203-01 53746-203 Amneal Pharmaceuticals of New York LLC 100 TABLET in 1 BOTTLE (53746-203-01) November 27, 2007
53746-203-05 53746-203 Amneal Pharmaceuticals of New York LLC 500 TABLET in 1 BOTTLE (53746-203-05) November 27, 2007
53746-204-01 53746-204 Amneal Pharmaceuticals of New York LLC 100 TABLET in 1 BOTTLE (53746-204-01) November 27, 2007
53746-204-05 53746-204 Amneal Pharmaceuticals of New York LLC 500 TABLET in 1 BOTTLE (53746-204-05) November 27, 2007
76420-136-30 76420-136 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (76420-136-30) August 28, 2021
76420-209-01 76420-209 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE, PLASTIC (76420-209-01) May 5, 2022
76420-209-30 76420-209 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE, PLASTIC (76420-209-30) May 5, 2022
76420-209-60 76420-209 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE, PLASTIC (76420-209-60) May 5, 2022
76420-209-90 76420-209 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE, PLASTIC (76420-209-90) May 5, 2022
76420-320-01 76420-320 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (76420-320-01) April 15, 2025
76420-320-05 76420-320 Asclemed USA, Inc. 500 TABLET in 1 BOTTLE (76420-320-05) April 15, 2025
76420-320-30 76420-320 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (76420-320-30) April 15, 2025
76420-320-60 76420-320 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (76420-320-60) April 15, 2025
76420-320-90 76420-320 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (76420-320-90) April 15, 2025
76420-321-01 76420-321 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (76420-321-01) April 15, 2025
76420-321-05 76420-321 Asclemed USA, Inc. 500 TABLET in 1 BOTTLE (76420-321-05) April 15, 2025
76420-321-30 76420-321 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (76420-321-30) April 15, 2025
76420-321-60 76420-321 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (76420-321-60) April 15, 2025
76420-321-90 76420-321 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (76420-321-90) April 15, 2025
76420-322-01 76420-322 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (76420-322-01) April 15, 2025
76420-322-05 76420-322 Asclemed USA, Inc. 500 TABLET in 1 BOTTLE (76420-322-05) April 15, 2025
76420-322-30 76420-322 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (76420-322-30) April 15, 2025
76420-322-60 76420-322 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (76420-322-60) April 15, 2025
76420-322-90 76420-322 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (76420-322-90) April 15, 2025
76420-323-01 76420-323 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (76420-323-01) April 15, 2025
76420-323-05 76420-323 Asclemed USA, Inc. 500 TABLET in 1 BOTTLE (76420-323-05) April 15, 2025
76420-323-30 76420-323 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (76420-323-30) April 15, 2025
76420-323-60 76420-323 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (76420-323-60) April 15, 2025
76420-323-90 76420-323 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (76420-323-90) April 15, 2025
87063-032-01 87063-032 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (87063-032-01) November 25, 2025
87063-032-05 87063-032 Asclemed USA, Inc. 500 TABLET in 1 BOTTLE (87063-032-05) November 25, 2025
87063-032-10 87063-032 Asclemed USA, Inc. 10 TABLET in 1 BOTTLE (87063-032-10) November 25, 2025
87063-032-20 87063-032 Asclemed USA, Inc. 20 TABLET in 1 BOTTLE (87063-032-20) November 25, 2025
87063-032-30 87063-032 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (87063-032-30) November 25, 2025
87063-032-60 87063-032 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (87063-032-60) November 25, 2025
87063-032-90 87063-032 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (87063-032-90) November 25, 2025
87063-033-01 87063-033 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (87063-033-01) November 25, 2025
87063-033-05 87063-033 Asclemed USA, Inc. 500 TABLET in 1 BOTTLE (87063-033-05) November 25, 2025
87063-033-10 87063-033 Asclemed USA, Inc. 10 TABLET in 1 BOTTLE (87063-033-10) November 25, 2025
87063-033-20 87063-033 Asclemed USA, Inc. 20 TABLET in 1 BOTTLE (87063-033-20) November 25, 2025
87063-033-30 87063-033 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (87063-033-30) November 25, 2025
87063-033-60 87063-033 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (87063-033-60) November 25, 2025
87063-033-90 87063-033 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (87063-033-90) November 25, 2025
87063-034-01 87063-034 Asclemed USA, Inc. 100 TABLET in 1 BOTTLE (87063-034-01) November 25, 2025
87063-034-05 87063-034 Asclemed USA, Inc. 500 TABLET in 1 BOTTLE (87063-034-05) November 25, 2025
87063-034-10 87063-034 Asclemed USA, Inc. 10 TABLET in 1 BOTTLE (87063-034-10) November 25, 2025
87063-034-20 87063-034 Asclemed USA, Inc. 20 TABLET in 1 BOTTLE (87063-034-20) November 25, 2025
87063-034-30 87063-034 Asclemed USA, Inc. 30 TABLET in 1 BOTTLE (87063-034-30) November 25, 2025
87063-034-60 87063-034 Asclemed USA, Inc. 60 TABLET in 1 BOTTLE (87063-034-60) November 25, 2025
87063-034-90 87063-034 Asclemed USA, Inc. 90 TABLET in 1 BOTTLE (87063-034-90) November 25, 2025
13107-043-01 13107-043 Aurolife Pharma, LLC 100 TABLET in 1 BOTTLE (13107-043-01) July 15, 2013
13107-043-05 13107-043 Aurolife Pharma, LLC 500 TABLET in 1 BOTTLE (13107-043-05) July 15, 2013
13107-043-30 13107-043 Aurolife Pharma, LLC 30 TABLET in 1 BOTTLE (13107-043-30) July 15, 2013
13107-043-99 13107-043 Aurolife Pharma, LLC 1000 TABLET in 1 BOTTLE (13107-043-99) July 15, 2013
13107-044-01 13107-044 Aurolife Pharma, LLC 100 TABLET in 1 BOTTLE (13107-044-01) July 15, 2013
13107-044-05 13107-044 Aurolife Pharma, LLC 500 TABLET in 1 BOTTLE (13107-044-05) July 15, 2013
13107-044-30 13107-044 Aurolife Pharma, LLC 30 TABLET in 1 BOTTLE (13107-044-30) July 15, 2013
13107-044-99 13107-044 Aurolife Pharma, LLC 1000 TABLET in 1 BOTTLE (13107-044-99) July 15, 2013
13107-045-01 13107-045 Aurolife Pharma, LLC 100 TABLET in 1 BOTTLE (13107-045-01) July 15, 2013
13107-045-05 13107-045 Aurolife Pharma, LLC 500 TABLET in 1 BOTTLE (13107-045-05) July 15, 2013
13107-045-30 13107-045 Aurolife Pharma, LLC 30 TABLET in 1 BOTTLE (13107-045-30) July 15, 2013
13107-045-99 13107-045 Aurolife Pharma, LLC 1000 TABLET in 1 BOTTLE (13107-045-99) July 15, 2013
13107-046-01 13107-046 Aurolife Pharma, LLC 100 TABLET in 1 BOTTLE (13107-046-01) July 15, 2013
13107-046-05 13107-046 Aurolife Pharma, LLC 500 TABLET in 1 BOTTLE (13107-046-05) July 15, 2013
13107-046-30 13107-046 Aurolife Pharma, LLC 30 TABLET in 1 BOTTLE (13107-046-30) July 15, 2013
13107-046-99 13107-046 Aurolife Pharma, LLC 1000 TABLET in 1 BOTTLE (13107-046-99) July 15, 2013
50268-644-15 50268-644 AvPAK 50 BLISTER PACK in 1 BOX (50268-644-15) / 1 TABLET in 1 BLISTER PACK (50268-644-11) July 9, 2018
50268-645-15 50268-645 AvPAK 50 BLISTER PACK in 1 BOX (50268-645-15) / 1 TABLET in 1 BLISTER PACK (50268-645-11) July 9, 2018
50268-646-15 50268-646 AvPAK 50 BLISTER PACK in 1 BOX (50268-646-15) / 1 TABLET in 1 BLISTER PACK (50268-646-11) July 9, 2018
63629-8834-1 63629-8834 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (63629-8834-1) October 6, 2021
63629-8834-2 63629-8834 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (63629-8834-2) October 26, 2021
63629-8834-3 63629-8834 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (63629-8834-3) October 7, 2021
63629-8834-4 63629-8834 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (63629-8834-4) March 15, 2023
63629-8834-5 63629-8834 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (63629-8834-5) October 6, 2021
63629-8834-6 63629-8834 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (63629-8834-6) March 15, 2023
63629-8834-7 63629-8834 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (63629-8834-7) March 15, 2023
63629-8834-8 63629-8834 Bryant Ranch Prepack 75 TABLET in 1 BOTTLE (63629-8834-8) March 15, 2023
63629-8834-9 63629-8834 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (63629-8834-9) March 15, 2023
63629-8876-1 63629-8876 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE, PLASTIC (63629-8876-1) October 1, 2021
63629-8888-1 63629-8888 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (63629-8888-1) October 7, 2021
63629-8888-2 63629-8888 Bryant Ranch Prepack 12 TABLET in 1 BOTTLE (63629-8888-2) March 15, 2023
63629-8888-3 63629-8888 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (63629-8888-3) March 15, 2023
63629-8888-4 63629-8888 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (63629-8888-4) October 26, 2021
63629-8888-5 63629-8888 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (63629-8888-5) December 17, 2021
63629-8888-6 63629-8888 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (63629-8888-6) June 21, 2022
63629-9501-1 63629-9501 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE, PLASTIC (63629-9501-1) December 14, 2022
71335-0146-0 71335-0146 Bryant Ranch Prepack 112 TABLET in 1 BOTTLE (71335-0146-0) January 17, 2012
71335-0146-1 71335-0146 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-0146-1) January 17, 2012
71335-0146-2 71335-0146 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-0146-2) January 17, 2012
71335-0146-3 71335-0146 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-0146-3) January 17, 2012
71335-0146-4 71335-0146 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-0146-4) January 17, 2012
71335-0146-5 71335-0146 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-0146-5) January 17, 2012
71335-0146-6 71335-0146 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-0146-6) January 17, 2012
71335-0146-7 71335-0146 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-0146-7) January 17, 2012
71335-0146-8 71335-0146 Bryant Ranch Prepack 75 TABLET in 1 BOTTLE (71335-0146-8) January 17, 2012
71335-0146-9 71335-0146 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-0146-9) January 17, 2012
71335-0216-0 71335-0216 Bryant Ranch Prepack 25 TABLET in 1 BOTTLE (71335-0216-0) July 25, 2016
71335-0216-1 71335-0216 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-0216-1) July 25, 2016
71335-0216-2 71335-0216 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-0216-2) July 25, 2016
71335-0216-3 71335-0216 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-0216-3) July 25, 2016
71335-0216-4 71335-0216 Bryant Ranch Prepack 12 TABLET in 1 BOTTLE (71335-0216-4) July 25, 2016
71335-0216-5 71335-0216 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-0216-5) July 25, 2016
71335-0216-6 71335-0216 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-0216-6) July 25, 2016
71335-0216-7 71335-0216 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-0216-7) July 25, 2016
71335-0216-8 71335-0216 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-0216-8) July 25, 2016
71335-0216-9 71335-0216 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-0216-9) July 25, 2016
71335-0316-0 71335-0316 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-0316-0) January 17, 2012
71335-0316-1 71335-0316 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-0316-1) January 17, 2012
71335-0316-2 71335-0316 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-0316-2) January 17, 2012
71335-0316-3 71335-0316 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-0316-3) January 17, 2012
71335-0316-4 71335-0316 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-0316-4) January 17, 2012
71335-0316-5 71335-0316 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-0316-5) January 17, 2012
71335-0316-6 71335-0316 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-0316-6) January 17, 2012
71335-0316-7 71335-0316 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-0316-7) January 17, 2012
71335-0316-8 71335-0316 Bryant Ranch Prepack 168 TABLET in 1 BOTTLE (71335-0316-8) January 17, 2012
71335-0316-9 71335-0316 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-0316-9) January 17, 2012
71335-1036-1 71335-1036 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1036-1) January 7, 2019
71335-1036-2 71335-1036 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-1036-2) August 9, 2024
71335-1036-3 71335-1036 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1036-3) December 24, 2018
71335-1036-4 71335-1036 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-1036-4) August 9, 2024
71335-1036-5 71335-1036 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1036-5) December 24, 2018
71335-1036-6 71335-1036 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-1036-6) August 9, 2024
71335-1036-7 71335-1036 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-1036-7) August 9, 2024
71335-1036-8 71335-1036 Bryant Ranch Prepack 75 TABLET in 1 BOTTLE (71335-1036-8) August 9, 2024
71335-1036-9 71335-1036 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-1036-9) August 9, 2024
71335-1420-1 71335-1420 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1420-1) April 24, 2020
71335-1420-2 71335-1420 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-1420-2) March 5, 2020
71335-1420-3 71335-1420 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1420-3) June 22, 2020
71335-1420-4 71335-1420 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-1420-4) April 3, 2024
71335-1420-5 71335-1420 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1420-5) January 21, 2020
71335-1420-6 71335-1420 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-1420-6) April 3, 2024
71335-1420-7 71335-1420 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-1420-7) September 21, 2020
71335-1420-8 71335-1420 Bryant Ranch Prepack 75 TABLET in 1 BOTTLE (71335-1420-8) April 3, 2024
71335-1420-9 71335-1420 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-1420-9) April 3, 2024
71335-1472-0 71335-1472 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-1472-0) April 3, 2024
71335-1472-1 71335-1472 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-1472-1) June 23, 2020
71335-1472-2 71335-1472 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1472-2) March 31, 2020
71335-1472-3 71335-1472 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE, PLASTIC (71335-1472-3) February 28, 2020
71335-1472-4 71335-1472 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1472-4) February 14, 2020
71335-1472-5 71335-1472 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-1472-5) April 3, 2024
71335-1472-6 71335-1472 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-1472-6) June 22, 2020
71335-1472-7 71335-1472 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-1472-7) April 3, 2024
71335-1472-8 71335-1472 Bryant Ranch Prepack 168 TABLET in 1 BOTTLE (71335-1472-8) April 3, 2024
71335-1472-9 71335-1472 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-1472-9) April 3, 2024
71335-1492-0 71335-1492 Bryant Ranch Prepack 25 TABLET in 1 BOTTLE (71335-1492-0) April 3, 2024
71335-1492-1 71335-1492 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-1492-1) December 11, 2020
71335-1492-2 71335-1492 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-1492-2) September 21, 2020
71335-1492-3 71335-1492 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-1492-3) April 3, 2024
71335-1492-4 71335-1492 Bryant Ranch Prepack 12 TABLET in 1 BOTTLE (71335-1492-4) March 9, 2020
71335-1492-5 71335-1492 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-1492-5) March 6, 2020
71335-1492-6 71335-1492 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1492-6) January 21, 2020
71335-1492-7 71335-1492 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1492-7) June 11, 2020
71335-1492-8 71335-1492 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1492-8) April 22, 2020
71335-1492-9 71335-1492 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-1492-9) April 3, 2024
71335-1909-1 71335-1909 Bryant Ranch Prepack 21 TABLET in 1 BOTTLE, PLASTIC (71335-1909-1) May 15, 2026
71335-1909-2 71335-1909 Bryant Ranch Prepack 36 TABLET in 1 BOTTLE, PLASTIC (71335-1909-2) May 15, 2026
71335-1909-3 71335-1909 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE, PLASTIC (71335-1909-3) May 15, 2026
71335-1909-4 71335-1909 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE, PLASTIC (71335-1909-4) November 8, 2022
71335-1909-5 71335-1909 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE, PLASTIC (71335-1909-5) May 15, 2026
71335-1909-6 71335-1909 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE, PLASTIC (71335-1909-6) May 15, 2026
71335-1909-7 71335-1909 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE, PLASTIC (71335-1909-7) May 15, 2026
71335-1909-8 71335-1909 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE, PLASTIC (71335-1909-8) November 4, 2022
71335-1953-0 71335-1953 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-1953-0) October 13, 2022
71335-1953-1 71335-1953 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-1953-1) September 29, 2021
71335-1953-2 71335-1953 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1953-2) September 29, 2021
71335-1953-3 71335-1953 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1953-3) September 17, 2021
71335-1953-4 71335-1953 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1953-4) October 7, 2021
71335-1953-5 71335-1953 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-1953-5) October 13, 2022
71335-1953-6 71335-1953 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-1953-6) October 13, 2022
71335-1953-7 71335-1953 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-1953-7) October 13, 2022
71335-1953-8 71335-1953 Bryant Ranch Prepack 168 TABLET in 1 BOTTLE (71335-1953-8) October 13, 2022
71335-1953-9 71335-1953 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-1953-9) October 13, 2022
71335-1959-1 71335-1959 Bryant Ranch Prepack 21 TABLET in 1 BOTTLE (71335-1959-1) May 31, 2024
71335-1959-2 71335-1959 Bryant Ranch Prepack 36 TABLET in 1 BOTTLE (71335-1959-2) September 30, 2021
71335-1959-3 71335-1959 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-1959-3) May 31, 2024
71335-1959-4 71335-1959 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-1959-4) October 26, 2021
71335-1959-5 71335-1959 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-1959-5) May 31, 2024
71335-1959-6 71335-1959 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-1959-6) October 7, 2021
71335-1959-7 71335-1959 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-1959-7) October 26, 2021
71335-1959-8 71335-1959 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-1959-8) November 10, 2021
71335-2041-0 71335-2041 Bryant Ranch Prepack 25 TABLET in 1 BOTTLE (71335-2041-0) May 31, 2024
71335-2041-1 71335-2041 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-2041-1) March 14, 2022
71335-2041-2 71335-2041 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-2041-2) February 1, 2022
71335-2041-3 71335-2041 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-2041-3) May 31, 2024
71335-2041-4 71335-2041 Bryant Ranch Prepack 12 TABLET in 1 BOTTLE (71335-2041-4) May 31, 2024
71335-2041-5 71335-2041 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-2041-5) March 16, 2022
71335-2041-6 71335-2041 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2041-6) February 18, 2022
71335-2041-7 71335-2041 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2041-7) February 10, 2022
71335-2041-8 71335-2041 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2041-8) May 9, 2022
71335-2041-9 71335-2041 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-2041-9) May 31, 2024
71335-2049-1 71335-2049 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2049-1) February 28, 2022
71335-2049-2 71335-2049 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-2049-2) February 28, 2022
71335-2049-3 71335-2049 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2049-3) February 28, 2022
71335-2049-4 71335-2049 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-2049-4) February 28, 2022
71335-2049-5 71335-2049 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2049-5) February 28, 2022
71335-2049-6 71335-2049 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-2049-6) February 28, 2022
71335-2049-7 71335-2049 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-2049-7) February 28, 2022
71335-2049-8 71335-2049 Bryant Ranch Prepack 75 TABLET in 1 BOTTLE (71335-2049-8) February 28, 2022
71335-2049-9 71335-2049 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-2049-9) February 28, 2022
71335-2106-1 71335-2106 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-2106-1) July 5, 2022
71335-2106-2 71335-2106 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-2106-2) May 31, 2024
71335-2106-3 71335-2106 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-2106-3) July 11, 2022
71335-2106-4 71335-2106 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-2106-4) May 31, 2024
71335-2106-5 71335-2106 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-2106-5) June 10, 2022
71335-2106-6 71335-2106 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-2106-6) May 31, 2024
71335-2106-7 71335-2106 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-2106-7) May 31, 2024
71335-2106-8 71335-2106 Bryant Ranch Prepack 75 TABLET in 1 BOTTLE (71335-2106-8) May 31, 2024
71335-2106-9 71335-2106 Bryant Ranch Prepack 100 TABLET in 1 BOTTLE (71335-2106-9) May 31, 2024
71335-9674-0 71335-9674 Bryant Ranch Prepack 25 TABLET in 1 BOTTLE (71335-9674-0) April 13, 2026
71335-9674-1 71335-9674 Bryant Ranch Prepack 10 TABLET in 1 BOTTLE (71335-9674-1) August 20, 2024
71335-9674-2 71335-9674 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-9674-2) April 28, 2023
71335-9674-3 71335-9674 Bryant Ranch Prepack 28 TABLET in 1 BOTTLE (71335-9674-3) April 13, 2026
71335-9674-4 71335-9674 Bryant Ranch Prepack 12 TABLET in 1 BOTTLE (71335-9674-4) April 13, 2026
71335-9674-5 71335-9674 Bryant Ranch Prepack 40 TABLET in 1 BOTTLE (71335-9674-5) April 27, 2023
71335-9674-6 71335-9674 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-9674-6) June 1, 2023
71335-9674-7 71335-9674 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-9674-7) April 13, 2026
71335-9674-8 71335-9674 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-9674-8) May 23, 2023
71335-9674-9 71335-9674 Bryant Ranch Prepack 84 TABLET in 1 BOTTLE (71335-9674-9) April 13, 2026
71335-9675-1 71335-9675 Bryant Ranch Prepack 21 TABLET in 1 BOTTLE (71335-9675-1) April 13, 2026
71335-9675-2 71335-9675 Bryant Ranch Prepack 36 TABLET in 1 BOTTLE (71335-9675-2) April 13, 2026
71335-9675-3 71335-9675 Bryant Ranch Prepack 20 TABLET in 1 BOTTLE (71335-9675-3) April 13, 2026
71335-9675-4 71335-9675 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (71335-9675-4) April 13, 2026
71335-9675-5 71335-9675 Bryant Ranch Prepack 45 TABLET in 1 BOTTLE (71335-9675-5) April 13, 2026
71335-9675-6 71335-9675 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (71335-9675-6) April 13, 2026
71335-9675-7 71335-9675 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (71335-9675-7) April 13, 2026
71335-9675-8 71335-9675 Bryant Ranch Prepack 120 TABLET in 1 BOTTLE (71335-9675-8) April 13, 2026
72162-1338-3 72162-1338 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE (72162-1338-3) April 14, 2026
72162-1338-6 72162-1338 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE (72162-1338-6) April 14, 2026
72162-1338-9 72162-1338 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE (72162-1338-9) April 14, 2026
72162-1339-3 72162-1339 Bryant Ranch Prepack 30 TABLET in 1 BOTTLE, PLASTIC (72162-1339-3) April 3, 2026
72162-1339-5 72162-1339 Bryant Ranch Prepack 500 TABLET in 1 BOTTLE, PLASTIC (72162-1339-5) April 3, 2026
72162-1339-6 72162-1339 Bryant Ranch Prepack 60 TABLET in 1 BOTTLE, PLASTIC (72162-1339-6) April 3, 2026
72162-1339-9 72162-1339 Bryant Ranch Prepack 90 TABLET in 1 BOTTLE, PLASTIC (72162-1339-9) April 3, 2026
31722-191-01 31722-191 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-191-01) April 11, 2017
31722-191-05 31722-191 Camber Pharmaceuticals, Inc. 500 TABLET in 1 BOTTLE (31722-191-05) April 11, 2017
31722-192-01 31722-192 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-192-01) April 11, 2017
31722-192-05 31722-192 Camber Pharmaceuticals, Inc. 500 TABLET in 1 BOTTLE (31722-192-05) April 11, 2017
31722-193-01 31722-193 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-193-01) April 11, 2017
31722-193-05 31722-193 Camber Pharmaceuticals, Inc. 500 TABLET in 1 BOTTLE (31722-193-05) April 11, 2017
31722-194-01 31722-194 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-194-01) April 11, 2017
31722-194-05 31722-194 Camber Pharmaceuticals, Inc. 500 TABLET in 1 BOTTLE (31722-194-05) April 11, 2017
31722-948-01 31722-948 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-948-01) March 15, 2019
31722-948-05 31722-948 Camber Pharmaceuticals, Inc. 500 TABLET in 1 BOTTLE (31722-948-05) March 15, 2019
31722-949-01 31722-949 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-949-01) March 15, 2019
31722-949-05 31722-949 Camber Pharmaceuticals, Inc. 500 TABLET in 1 BOTTLE (31722-949-05) March 15, 2019
31722-950-01 31722-950 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-950-01) March 15, 2019
31722-950-05 31722-950 Camber Pharmaceuticals, Inc. 500 TABLET in 1 BOTTLE (31722-950-05) March 15, 2019
31722-951-01 31722-951 Camber Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (31722-951-01) March 15, 2019
31722-951-05 31722-951 Camber Pharmaceuticals, Inc. 500 TABLET in 1 BOTTLE (31722-951-05) March 15, 2019
72189-255-30 72189-255 DIRECT RX 30 TABLET in 1 BOTTLE (72189-255-30) August 10, 2021
72189-255-60 72189-255 DIRECT RX 60 TABLET in 1 BOTTLE (72189-255-60) August 10, 2021
72189-256-30 72189-256 DIRECT RX 30 TABLET in 1 BOTTLE (72189-256-30) August 10, 2021
72189-256-60 72189-256 DIRECT RX 60 TABLET in 1 BOTTLE (72189-256-60) August 10, 2021
72189-256-72 72189-256 DIRECT RX 120 TABLET in 1 BOTTLE (72189-256-72) August 10, 2021
61919-871-60 61919-871 Direct_Rx 60 TABLET in 1 BOTTLE (61919-871-60) August 21, 2019
61919-871-72 61919-871 Direct_Rx 120 TABLET in 1 BOTTLE (61919-871-72) August 21, 2019
72189-368-30 72189-368 Direct_Rx 30 TABLET in 1 BOTTLE (72189-368-30) July 28, 2022
72189-368-60 72189-368 Direct_Rx 60 TABLET in 1 BOTTLE (72189-368-60) July 28, 2022
72189-368-72 72189-368 Direct_Rx 120 TABLET in 1 BOTTLE (72189-368-72) July 28, 2022
72189-368-90 72189-368 Direct_Rx 90 TABLET in 1 BOTTLE (72189-368-90) July 28, 2022
42806-114-01 42806-114 Epic Pharma, LLC 100 TABLET in 1 BOTTLE (42806-114-01) July 2, 2018
42806-115-01 42806-115 Epic Pharma, LLC 100 TABLET in 1 BOTTLE (42806-115-01) July 2, 2018
42806-116-01 42806-116 Epic Pharma, LLC 100 TABLET in 1 BOTTLE (42806-116-01) July 2, 2018
71930-045-12 71930-045 Eywa Pharma Inc 100 TABLET in 1 BOTTLE (71930-045-12) June 1, 2019
71930-045-52 71930-045 Eywa Pharma Inc 500 TABLET in 1 BOTTLE (71930-045-52) June 1, 2019
71930-046-12 71930-046 Eywa Pharma Inc 100 TABLET in 1 BOTTLE (71930-046-12) June 1, 2019
71930-046-52 71930-046 Eywa Pharma Inc 500 TABLET in 1 BOTTLE (71930-046-52) June 1, 2019
71930-047-12 71930-047 Eywa Pharma Inc 100 TABLET in 1 BOTTLE (71930-047-12) June 1, 2019
71930-047-52 71930-047 Eywa Pharma Inc 500 TABLET in 1 BOTTLE (71930-047-52) June 1, 2019
72887-193-03 72887-193 FH2 Pharma LLC 30 TABLET in 1 BOTTLE, PLASTIC (72887-193-03) June 3, 2019
72887-681-03 72887-681 FH2 Pharma LLC 30 TABLET in 1 BOTTLE, PLASTIC (72887-681-03) September 25, 2020
72887-682-03 72887-682 FH2 Pharma LLC 30 TABLET in 1 BOTTLE (72887-682-03) March 2, 2021
72887-683-03 72887-683 FH2 Pharma LLC 30 TABLET in 1 BOTTLE, PLASTIC (72887-683-03) September 25, 2020
70010-667-01 70010-667 Granules Pharmaceuticals Inc. 100 TABLET in 1 BOTTLE (70010-667-01) January 1, 2022
70010-667-05 70010-667 Granules Pharmaceuticals Inc. 500 TABLET in 1 BOTTLE (70010-667-05) January 1, 2022
70010-668-01 70010-668 Granules Pharmaceuticals Inc. 100 TABLET in 1 BOTTLE (70010-668-01) January 1, 2022
70010-668-05 70010-668 Granules Pharmaceuticals Inc. 500 TABLET in 1 BOTTLE (70010-668-05) January 1, 2022
70010-669-01 70010-669 Granules Pharmaceuticals Inc. 100 TABLET in 1 BOTTLE (70010-669-01) January 1, 2022
70010-669-05 70010-669 Granules Pharmaceuticals Inc. 500 TABLET in 1 BOTTLE (70010-669-05) January 1, 2022
70010-670-01 70010-670 Granules Pharmaceuticals Inc. 100 TABLET in 1 BOTTLE (70010-670-01) January 1, 2022
70010-670-05 70010-670 Granules Pharmaceuticals Inc. 500 TABLET in 1 BOTTLE (70010-670-05) January 1, 2022
10702-184-01 10702-184 KVK-Tech, Inc. 100 TABLET in 1 BOTTLE (10702-184-01) February 9, 2018
10702-184-10 10702-184 KVK-Tech, Inc. 1000 TABLET in 1 BOTTLE (10702-184-10) February 9, 2018
10702-184-50 10702-184 KVK-Tech, Inc. 500 TABLET in 1 BOTTLE (10702-184-50) February 9, 2018
10702-185-01 10702-185 KVK-Tech, Inc. 100 TABLET in 1 BOTTLE (10702-185-01) February 9, 2018
10702-185-10 10702-185 KVK-Tech, Inc. 1000 TABLET in 1 BOTTLE (10702-185-10) February 9, 2018
10702-185-50 10702-185 KVK-Tech, Inc. 500 TABLET in 1 BOTTLE (10702-185-50) February 9, 2018
10702-186-01 10702-186 KVK-Tech, Inc. 100 TABLET in 1 BOTTLE (10702-186-01) February 9, 2018
10702-186-10 10702-186 KVK-Tech, Inc. 1000 TABLET in 1 BOTTLE (10702-186-10) February 9, 2018
10702-186-50 10702-186 KVK-Tech, Inc. 500 TABLET in 1 BOTTLE (10702-186-50) February 9, 2018
10702-187-01 10702-187 KVK-Tech, Inc. 100 TABLET in 1 BOTTLE (10702-187-01) February 9, 2018
10702-187-10 10702-187 KVK-Tech, Inc. 1000 TABLET in 1 BOTTLE (10702-187-10) February 9, 2018
10702-187-50 10702-187 KVK-Tech, Inc. 500 TABLET in 1 BOTTLE (10702-187-50) February 9, 2018
43386-493-01 43386-493 Lupin Pharmaceuticals,Inc. 100 TABLET in 1 BOTTLE (43386-493-01) February 24, 2017
43386-493-05 43386-493 Lupin Pharmaceuticals,Inc. 500 TABLET in 1 BOTTLE (43386-493-05) February 24, 2017
0904-7093-61 0904-7093 Major Pharmaceuticals 100 BLISTER PACK in 1 CARTON (0904-7093-61) / 1 TABLET in 1 BLISTER PACK June 1, 2019
0904-7094-61 0904-7094 Major Pharmaceuticals 100 BLISTER PACK in 1 CARTON (0904-7094-61) / 1 TABLET in 1 BLISTER PACK June 1, 2019
0904-7095-61 0904-7095 Major Pharmaceuticals 100 BLISTER PACK in 1 CARTON (0904-7095-61) / 1 TABLET in 1 BLISTER PACK June 1, 2019
68071-3683-6 68071-3683 NuCare Pharmaceuticals,Inc. 6 TABLET in 1 BOTTLE (68071-3683-6) September 16, 2024
68071-5054-2 68071-5054 NuCare Pharmaceuticals,Inc. 12 TABLET in 1 BOTTLE (68071-5054-2) September 12, 2019
68071-5054-4 68071-5054 NuCare Pharmaceuticals,Inc. 4 TABLET in 1 BOTTLE (68071-5054-4) September 12, 2019
68071-5054-6 68071-5054 NuCare Pharmaceuticals,Inc. 6 TABLET in 1 BOTTLE (68071-5054-6) September 12, 2019
68071-5169-2 68071-5169 NuCare Pharmaceuticals,Inc. 20 TABLET in 1 BOTTLE (68071-5169-2) February 10, 2020
63187-363-12 63187-363 Proficient Rx LP 12 TABLET in 1 BOTTLE (63187-363-12) November 1, 2016
63187-363-15 63187-363 Proficient Rx LP 15 TABLET in 1 BOTTLE (63187-363-15) August 1, 2016
63187-363-20 63187-363 Proficient Rx LP 20 TABLET in 1 BOTTLE (63187-363-20) August 1, 2016
63187-363-30 63187-363 Proficient Rx LP 30 TABLET in 1 BOTTLE (63187-363-30) August 1, 2016
63187-363-60 63187-363 Proficient Rx LP 60 TABLET in 1 BOTTLE (63187-363-60) August 1, 2016
63187-719-12 63187-719 Proficient Rx LP 12 TABLET in 1 BOTTLE (63187-719-12) November 1, 2016
63187-719-15 63187-719 Proficient Rx LP 15 TABLET in 1 BOTTLE (63187-719-15) June 1, 2016
63187-719-20 63187-719 Proficient Rx LP 20 TABLET in 1 BOTTLE (63187-719-20) June 1, 2016
63187-719-30 63187-719 Proficient Rx LP 30 TABLET in 1 BOTTLE (63187-719-30) June 1, 2016
63187-719-60 63187-719 Proficient Rx LP 60 TABLET in 1 BOTTLE (63187-719-60) June 1, 2016
63187-721-15 63187-721 Proficient Rx LP 15 TABLET in 1 BOTTLE (63187-721-15) June 1, 2016
63187-721-20 63187-721 Proficient Rx LP 20 TABLET in 1 BOTTLE (63187-721-20) June 1, 2016
63187-721-30 63187-721 Proficient Rx LP 30 TABLET in 1 BOTTLE (63187-721-30) June 1, 2016
63187-721-60 63187-721 Proficient Rx LP 60 TABLET in 1 BOTTLE (63187-721-60) June 1, 2016
63187-721-90 63187-721 Proficient Rx LP 90 TABLET in 1 BOTTLE (63187-721-90) May 30, 2017
63187-823-15 63187-823 Proficient Rx LP 15 TABLET in 1 BOTTLE (63187-823-15) December 1, 2016
63187-823-20 63187-823 Proficient Rx LP 20 TABLET in 1 BOTTLE (63187-823-20) December 1, 2016
63187-823-30 63187-823 Proficient Rx LP 30 TABLET in 1 BOTTLE (63187-823-30) December 1, 2016
63187-823-60 63187-823 Proficient Rx LP 60 TABLET in 1 BOTTLE (63187-823-60) December 1, 2016
63187-823-90 63187-823 Proficient Rx LP 90 TABLET in 1 BOTTLE (63187-823-90) March 1, 2017
63187-824-10 63187-824 Proficient Rx LP 10 TABLET in 1 BOTTLE, PLASTIC (63187-824-10) December 1, 2017
63187-824-12 63187-824 Proficient Rx LP 12 TABLET in 1 BOTTLE, PLASTIC (63187-824-12) March 1, 2017
63187-824-15 63187-824 Proficient Rx LP 15 TABLET in 1 BOTTLE, PLASTIC (63187-824-15) August 28, 2014
63187-824-20 63187-824 Proficient Rx LP 20 TABLET in 1 BOTTLE, PLASTIC (63187-824-20) August 28, 2014
63187-824-30 63187-824 Proficient Rx LP 30 TABLET in 1 BOTTLE, PLASTIC (63187-824-30) March 1, 2017
63187-824-60 63187-824 Proficient Rx LP 60 TABLET in 1 BOTTLE, PLASTIC (63187-824-60) March 1, 2017
63187-824-90 63187-824 Proficient Rx LP 90 TABLET in 1 BOTTLE, PLASTIC (63187-824-90) March 1, 2017
63187-984-10 63187-984 Proficient Rx LP 10 TABLET in 1 BOTTLE (63187-984-10) February 1, 2018
63187-984-12 63187-984 Proficient Rx LP 12 TABLET in 1 BOTTLE (63187-984-12) February 1, 2018
63187-984-15 63187-984 Proficient Rx LP 15 TABLET in 1 BOTTLE (63187-984-15) February 1, 2018
63187-984-30 63187-984 Proficient Rx LP 30 TABLET in 1 BOTTLE (63187-984-30) February 1, 2018
63187-984-60 63187-984 Proficient Rx LP 60 TABLET in 1 BOTTLE (63187-984-60) February 1, 2018
71205-329-10 71205-329 Proficient Rx LP 10 TABLET in 1 BOTTLE (71205-329-10) December 23, 2019
71205-329-28 71205-329 Proficient Rx LP 28 TABLET in 1 BOTTLE (71205-329-28) August 29, 2022
71205-329-30 71205-329 Proficient Rx LP 30 TABLET in 1 BOTTLE (71205-329-30) September 1, 2019
71205-329-60 71205-329 Proficient Rx LP 60 TABLET in 1 BOTTLE (71205-329-60) September 1, 2019
71205-329-90 71205-329 Proficient Rx LP 90 TABLET in 1 BOTTLE (71205-329-90) September 1, 2019
71205-347-12 71205-347 Proficient Rx LP 12 TABLET in 1 BOTTLE (71205-347-12) November 1, 2019
71205-347-15 71205-347 Proficient Rx LP 15 TABLET in 1 BOTTLE (71205-347-15) November 1, 2019
71205-347-20 71205-347 Proficient Rx LP 20 TABLET in 1 BOTTLE (71205-347-20) November 1, 2019
71205-347-30 71205-347 Proficient Rx LP 30 TABLET in 1 BOTTLE (71205-347-30) November 1, 2019
71205-347-60 71205-347 Proficient Rx LP 60 TABLET in 1 BOTTLE (71205-347-60) November 1, 2019
71205-347-90 71205-347 Proficient Rx LP 90 TABLET in 1 BOTTLE (71205-347-90) November 1, 2019
71205-486-30 71205-486 Proficient Rx LP 30 TABLET in 1 BOTTLE (71205-486-30) October 14, 2020
71205-486-60 71205-486 Proficient Rx LP 60 TABLET in 1 BOTTLE (71205-486-60) October 14, 2020
71205-486-90 71205-486 Proficient Rx LP 90 TABLET in 1 BOTTLE (71205-486-90) October 14, 2020
49999-852-14 49999-852 Quality Care products LLC 14 TABLET in 1 BOTTLE, PLASTIC (49999-852-14) August 10, 2022
49999-852-30 49999-852 Quality Care products LLC 30 TABLET in 1 BOTTLE, PLASTIC (49999-852-30) August 3, 2022
49999-852-60 49999-852 Quality Care products LLC 60 TABLET in 1 BOTTLE, PLASTIC (49999-852-60) August 3, 2022
49999-852-90 49999-852 Quality Care products LLC 90 TABLET in 1 BOTTLE, PLASTIC (49999-852-90) August 3, 2022
67296-1937-0 67296-1937 RedPharm Drug 4 TABLET in 1 BOTTLE (67296-1937-0) August 28, 2014
67296-1937-1 67296-1937 RedPharm Drug 10 TABLET in 1 BOTTLE (67296-1937-1) August 28, 2014
67296-1937-2 67296-1937 RedPharm Drug 20 TABLET in 1 BOTTLE (67296-1937-2) August 28, 2014
67296-1937-3 67296-1937 RedPharm Drug 12 TABLET in 1 BOTTLE (67296-1937-3) August 28, 2014
67296-1937-6 67296-1937 RedPharm Drug 6 TABLET in 1 BOTTLE (67296-1937-6) August 28, 2014
67296-1937-7 67296-1937 RedPharm Drug 15 TABLET in 1 BOTTLE (67296-1937-7) August 28, 2014
42858-102-01 42858-102 Rhodes Pharmaceuticals LLC 100 TABLET in 1 BOTTLE, PLASTIC (42858-102-01) August 28, 2014
42858-102-10 42858-102 Rhodes Pharmaceuticals LLC 10 BLISTER PACK in 1 CARTON (42858-102-10) / 10 TABLET in 1 BLISTER PACK August 28, 2014
42858-102-50 42858-102 Rhodes Pharmaceuticals LLC 500 TABLET in 1 BOTTLE, PLASTIC (42858-102-50) August 28, 2014
42858-103-01 42858-103 Rhodes Pharmaceuticals LLC 100 TABLET in 1 BOTTLE, PLASTIC (42858-103-01) August 28, 2014
42858-103-10 42858-103 Rhodes Pharmaceuticals LLC 10 BLISTER PACK in 1 CARTON (42858-103-10) / 10 TABLET in 1 BLISTER PACK August 28, 2014
42858-103-50 42858-103 Rhodes Pharmaceuticals LLC 500 TABLET in 1 BOTTLE, PLASTIC (42858-103-50) August 28, 2014
42858-104-01 42858-104 Rhodes Pharmaceuticals LLC 100 TABLET in 1 BOTTLE, PLASTIC (42858-104-01) August 28, 2014
42858-104-10 42858-104 Rhodes Pharmaceuticals LLC 10 BLISTER PACK in 1 CARTON (42858-104-10) / 10 TABLET in 1 BLISTER PACK August 28, 2014
42858-104-50 42858-104 Rhodes Pharmaceuticals LLC 500 TABLET in 1 BOTTLE, PLASTIC (42858-104-50) August 28, 2014
0406-0512-01 0406-0512 SpecGx LLC 100 TABLET in 1 BOTTLE (0406-0512-01) December 7, 1983
0406-0512-05 0406-0512 SpecGx LLC 500 TABLET in 1 BOTTLE (0406-0512-05) December 7, 1983
0406-0512-23 0406-0512 SpecGx LLC 1 TABLET in 1 BLISTER PACK (0406-0512-23) December 7, 1983
0406-0512-62 0406-0512 SpecGx LLC 100 TABLET in 1 BLISTER PACK (0406-0512-62) December 7, 1983
0406-0512-91 0406-0512 SpecGx LLC 5000 TABLET in 1 PAIL (0406-0512-91) December 7, 1983
0406-0522-01 0406-0522 SpecGx LLC 100 TABLET in 1 BOTTLE (0406-0522-01) June 30, 2004
0406-0522-05 0406-0522 SpecGx LLC 500 TABLET in 1 BOTTLE (0406-0522-05) June 30, 2004
0406-0522-23 0406-0522 SpecGx LLC 1 TABLET in 1 BLISTER PACK (0406-0522-23) June 30, 2004
0406-0522-62 0406-0522 SpecGx LLC 100 TABLET in 1 BLISTER PACK (0406-0522-62) June 30, 2004
0406-0523-01 0406-0523 SpecGx LLC 100 TABLET in 1 BOTTLE (0406-0523-01) June 30, 2004
0406-0523-05 0406-0523 SpecGx LLC 500 TABLET in 1 BOTTLE (0406-0523-05) June 30, 2004
0406-0523-23 0406-0523 SpecGx LLC 1 TABLET in 1 BLISTER PACK (0406-0523-23) June 30, 2004
0406-0523-62 0406-0523 SpecGx LLC 100 TABLET in 1 BLISTER PACK (0406-0523-62) June 30, 2004
60760-897-30 60760-897 St. Mary's Medical Park Pharmacy 30 TABLET in 1 BOTTLE, PLASTIC (60760-897-30) August 20, 2025
60760-897-60 60760-897 St. Mary's Medical Park Pharmacy 60 TABLET in 1 BOTTLE, PLASTIC (60760-897-60) August 20, 2025
60760-898-30 60760-898 St. Mary's Medical Park Pharmacy 30 TABLET in 1 BOTTLE, PLASTIC (60760-898-30) August 21, 2025
60760-898-60 60760-898 St. Mary's Medical Park Pharmacy 60 TABLET in 1 BOTTLE, PLASTIC (60760-898-60) August 21, 2025
60760-899-30 60760-899 St. Mary's Medical Park Pharmacy 30 TABLET in 1 BOTTLE, PLASTIC (60760-899-30) August 21, 2025
60760-899-60 60760-899 St. Mary's Medical Park Pharmacy 60 TABLET in 1 BOTTLE, PLASTIC (60760-899-60) August 21, 2025

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 · 12 sections on this page.