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temazepam

Prescription ANDA Schedule CIV TE AB 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
temazepam
Generic name
temazepam
Dosage form
Capsule
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Bryant Ranch Prepack
Product type
Human Prescription Drug
DEA schedule
CIV
Active ingredients
4
NDC product codes
84
Packages
235
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Temazepam 15 mg/1 198241 View
Temazepam 22.5 mg/1 198241 View
Temazepam 30 mg/1 198241 View
Temazepam 7.5 mg/1 198241 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
319

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
Benzodiazepine [EPC] EPC All 48 members
Benzodiazepines [CS] CS All 48 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
071457
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 21, 1987
Sponsor
NOVEL LABS INC
Products on application
3
Submissions recorded
14
Products approved under application 071457.
Product Trade name Form Strength Ingredient Status TE Flags
071457-001 TEMAZEPAM CAPSULE TEMAZEPAM Prescription AB
071457-002 TEMAZEPAM CAPSULE TEMAZEPAM Prescription AB
071457-003 TEMAZEPAM CAPSULE TEMAZEPAM Prescription AB

Therapeutic equivalence

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

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

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 071457.
Type No. Action Status Date Review
Supplement 19 Labeling Approved August 19, 2024 Standard
Supplement 17 Labeling Approved August 3, 2022 Standard
Supplement 14 Labeling Approved August 27, 2019 Standard
Supplement 11 Manufacturing (CMC) Approved June 22, 2012 —
Supplement 10 Manufacturing (CMC) Approved June 22, 2012 —
Supplement 9 Labeling Approved April 17, 2012 —
Supplement 6 Labeling Approved July 7, 2004 —
Supplement 5 Labeling Approved December 28, 1993 —
Supplement 4 Labeling Approved February 4, 1991 —
Supplement 1 Manufacturing (CMC) Approved July 31, 1989 —
Supplement 21 Labeling Approved June 12, 1989 —
Supplement 3 Labeling Approved June 12, 1989 —
Supplement 2 Manufacturing (CMC) Approved November 4, 1987 —
Original application 1 Approved April 21, 1987 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251008). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20251008 HUMAN PRESCRIPTION DRUG · 20250929 HUMAN PRESCRIPTION DRUG · 20241231 HUMAN PRESCRIPTION DRUG · 20240829

Boxed Warning

openFDA Drug Labeling

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation ( see WARNINGS and PRECAUTIONS) . • The use of benzodiazepines, including temazepam capsules, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing temazepam capsules and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction ( see WARNINGS). • The continued use of benzodiazepines, including temazepam capsules, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of temazepam capsules after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam capsules or reduce the dosage ( see DOSAGE AND ADMINISTRATION and WARNINGS).

Indications and Usage

openFDA Drug Labeling

INDICATIONS AND USAGE Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules, USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.

Dosage and Administration

openFDA Drug Labeling

DOSAGE AND ADMINISTRATION While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined. Discontinuation or Dosage Reduction of Temazepam Capsules To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam capsules or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly ( see WARNINGS, Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence ).

Contraindications

openFDA Drug Labeling

CONTRAINDICATIONS Benzodiazepines may cause fetal harm when administered to a pregnant woman. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. Reproduction studies in animals with temazepam were performed in rats and rabbits. In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality. Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher. In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls. Temazepam capsules are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.

Warnings and Cautions

openFDA Drug Labeling

Warnings and Precautions Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including Temazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug related mortality compared to use of opioids alone. If a decision is made to prescribe Temazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of Temazepam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking Temazepam, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when Temazepam is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see PRECAUTIONS, DRUG INTERACTIONS). Abuse, Misuse, and Addiction The use of benzodiazepines, including temazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see DRUG ABUSE AND DEPENDENCE, Abuse). Before prescribing temazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of temazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of temazepam along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. Dependence and Withdrawal Reactions To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage (a patient-specific plan should be used to taper the dose) (see DOSAGE AND ADMINISTRATION, Discontinuation or Dosage Reduction of temazepam). Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. Acute Withdrawal Reactions The continued use of benzodiazepines, including temazepam, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of temazepam after continued use , or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE, Dependence). Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see DRUG ABUSE AND DEPENDENCE, Dependence). Sleep disturbance may be the presenting manifestation of an underlying physical and/or psychiatric disorder. Consequently, a de …

WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including temazepam capsules, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe temazepam capsules concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of temazepam capsules than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking temazepam capsules, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when temazepam capsules are used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined ( see PRECAUTIONS, Drug Interactions ). Abuse, Misuse, and Addiction The use of benzodiazepines, including temazepam capsules, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death ( see DRUG ABUSE AND DEPENDENCE, Abuse ). Before prescribing temazepam capsules and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). Use of temazepam capsules, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of temazepam capsules along with monitoring for signs and symptoms of abuse, misuse, and addiction. Prescribe the lowest effective dosage; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. Dependence and Withdrawal Reactions To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam capsules or reduce the dosage (a patient-specific plan should be used to taper the dose) ( see DOSAGE AND ADMINISTRATION, Discontinuation or Dosage Reduction of Temazepam Capsules ). Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. Acute Withdrawal Reactions The continued use of benzodiazepines, including temazepam capsules, may lead to clinically significant physical dependence. Abrupt discontinuation or rapid dosage reduction of temazepam capsules after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) ( see DRUG ABUSE AND DEPENDENCE, Dependence ). Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months ( see DRUG ABUSE AND DEPENDENCE, Dependence ). Sleep disturbanc …

Adverse Reactions

openFDA Drug Labeling

ADVERSE REACTIONS During controlled clinical studies in which 1076 patients received temazepam at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table: Temazepam Placebo % Incidence (n=1076) % Incidence (n=783) Drowsiness 9.1 5.6 Headache 8.5 9.1 Fatigue 4.8 4.7 Nervousness 4.6 8.2 Lethargy 4.5 3.4 Dizziness 4.5 3.3 Nausea 3.1 3.8 Hangover 2.5 1.1 Anxiety 2.0 1.5 Depression 1.7 1.8 Dry Mouth 1.7 2.2 Diarrhea 1.7 1.1 Abdominal Discomfort 1.5 1.9 Euphoria 1.5 0.4 Weakness 1.4 0.9 Confusion 1.3 0.5 Blurred Vision 1.3 1.3 Nightmares 1.2 1.7 Vertigo 1.2 0.8 The following adverse events have been reported less frequently (0.5% to 0.9%): Central Nervous System – anorexia, ataxia, equilibrium loss, tremor, increased dreaming Cardiovascular – dyspnea, palpitations Gastrointestinal – vomiting Musculoskeletal – backache Special Senses – hyperhidrosis, burning eyes Amnesia, hallucinations, horizontal nystagmus, and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%). To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

Drug Interactions

openFDA Drug Labeling

Drug Interactions The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. The benzodiazepines, including temazepam, produce additive CNS-depressant effects when co-administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics. The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.

Description

openFDA Drug Labeling

DESCRIPTION Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2 H -1,4-benzodiazepin-2-one, and the structural formula is: C 16 H 13 CIN 2 O 2 MW = 300.74 Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules, USP, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. 7.5 mg, 15 mg, 22.5 mg and 30 mg Capsules Active Ingredient: temazepam USP 7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. Structural Formula

OVERDOSAGE Manifestations of acute overdosage of temazepam capsules can be expected to reflect the CNS effects of the drug and include somnolence, confusion, and coma, with reduced or absent reflexes, respiratory depression, and hypotension. The oral LD 50 of temazepam capsules were 1963 mg/kg in mice, 1833 mg/kg in rats, and >2400 mg/kg in rabbits. Treatment If the patient is conscious, vomiting should be induced mechanically or with emetics. Gastric lavage should be employed utilizing concurrently a cuffed endotracheal tube if the patient is unconscious to prevent aspiration and pulmonary complications. Maintenance of adequate pulmonary ventilation is essential. The use of pressor agents intravenously may be necessary to combat hypotension. Fluids should be administered intravenously to encourage diuresis. The value of dialysis has not been determined. If excitation occurs, barbiturates should not be used. It should be borne in mind that multiple agents may have been ingested. Flumazenil (Romazicon ® ) * , a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS should be consulted prior to use. Up-to-date information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians' Desk Reference ®** .

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Temazepam Capsules USP 7.5 mg Pink opaque cap and white opaque body, imprinted “7.5 mg” on cap and “Novel 120” on the body in black ink. Bottle of 30 NDC 76420-472-30 (repackaged/relabeled from NDC 67877-148-30) Bottle of 60 NDC 76420-472-60 (repackaged from NDC 67877-148-XX) Bottle of 90 NDC 76420-472-90 (repackaged from NDC 67877-148-XX) Bottle of 100 NDC 76420-472-01 (relabeled from NDC 67877-148-01) Bottle of 500 NDC 76420-472-05 (relabeled from NDC 67877-148-05) 15 mg Blue opaque cap and white opaque body, imprinted “15 mg” on cap and “Novel 121” on the body in black ink. Bottle of 30 NDC 76420-473-30 (repackaged from NDC 67877-146-XX) Bottle of 60 NDC 76420-473-60 (repackaged from NDC 67877-146-XX) Bottle of 90 NDC 76420-473-90 (repackaged from NDC 67877-146-XX) Bottle of 100 NDC 76420-473-01 (relabeled from NDC 67877-146-01) Bottle of 500 NDC 76420-473-05 (relabeled from NDC 67877-146-05) 22.5 mg Light blue opaque cap and white opaque body, imprinted “22.5 mg” on cap and “Novel 122” on the body in black ink. Bottle of 30 NDC 76420-474-30 (relabeled from NDC 67877-149-30) Bottle of 60 NDC 76420-474-60 (repackaged from NDC 67877-149-XX) Bottle of 90 NDC 76420-474-90 (repackaged from NDC 67877-149-XX) Bottle of 100 NDC 76420-474-01 (relabeled from NDC 67877-149-01) Bottle of 500 NDC 76420-474-05 (relabeled from NDC 67877-149-05) 30 mg White opaque cap and body, imprinted “30 mg” on cap and “Novel 123” on the body in black ink. Bottle of 30 NDC 76420-475-30 (repackaged from NDC 67877-147-XX) Bottle of 60 NDC 76420-475-60 (repackaged from NDC 67877-147-XX) Bottle of 90 NDC 76420-475-90 (repackaged from NDC 67877-147-XX) Bottle of 100 NDC 76420-475-01 (relabeled from NDC 67877-147-01) Bottle of 500 NDC 76420-475-05 (relabeled from NDC 67877-147-05) Dispense in a well-closed, light-resistant container with a child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Adverse event reports

Source: openFDA FAERS
37,477
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: TEMAZEPAM. 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.

Packaging and NDCs

Source: NDC Directory
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
50090-0186-0 50090-0186 A-S Medication Solutions 30 CAPSULE in 1 BOTTLE (50090-0186-0) November 28, 2014
50090-0285-1 50090-0285 A-S Medication Solutions 30 CAPSULE in 1 BOTTLE (50090-0285-1) November 28, 2014
0228-2076-10 0228-2076 Actavis Pharma, Inc. 100 CAPSULE in 1 BOTTLE (0228-2076-10) September 30, 1990
0228-2076-50 0228-2076 Actavis Pharma, Inc. 500 CAPSULE in 1 BOTTLE (0228-2076-50) September 30, 1990
0228-2077-10 0228-2077 Actavis Pharma, Inc. 100 CAPSULE in 1 BOTTLE (0228-2077-10) September 30, 1990
0228-2077-50 0228-2077 Actavis Pharma, Inc. 500 CAPSULE in 1 BOTTLE (0228-2077-50) September 30, 1990
80425-0191-1 80425-0191 Advanced Rx Pharmacy of Tennessee, LLC 20 CAPSULE in 1 BOTTLE (80425-0191-1) February 17, 2024
80425-0191-2 80425-0191 Advanced Rx Pharmacy of Tennessee, LLC 30 CAPSULE in 1 BOTTLE (80425-0191-2) March 30, 2023
80425-0295-1 80425-0295 Advanced Rx Pharmacy of Tennessee, LLC 30 CAPSULE in 1 BOTTLE (80425-0295-1) April 4, 2023
80425-0295-2 80425-0295 Advanced Rx Pharmacy of Tennessee, LLC 60 CAPSULE in 1 BOTTLE (80425-0295-2) April 4, 2023
80425-0295-3 80425-0295 Advanced Rx Pharmacy of Tennessee, LLC 90 CAPSULE in 1 BOTTLE (80425-0295-3) April 4, 2023
62332-379-30 62332-379 Alembic Pharmaceuticals Inc. 30 CAPSULE in 1 BOTTLE (62332-379-30) November 27, 2018
62332-379-31 62332-379 Alembic Pharmaceuticals Inc. 100 CAPSULE in 1 BOTTLE (62332-379-31) November 27, 2018
62332-380-30 62332-380 Alembic Pharmaceuticals Inc. 30 CAPSULE in 1 BOTTLE (62332-380-30) November 27, 2018
62332-380-31 62332-380 Alembic Pharmaceuticals Inc. 100 CAPSULE in 1 BOTTLE (62332-380-31) November 27, 2018
62332-380-71 62332-380 Alembic Pharmaceuticals Inc. 500 CAPSULE in 1 BOTTLE (62332-380-71) November 27, 2018
62332-380-90 62332-380 Alembic Pharmaceuticals Inc. 90 CAPSULE in 1 BOTTLE (62332-380-90) November 27, 2018
62332-381-30 62332-381 Alembic Pharmaceuticals Inc. 30 CAPSULE in 1 BOTTLE (62332-381-30) November 27, 2018
62332-382-30 62332-382 Alembic Pharmaceuticals Inc. 30 CAPSULE in 1 BOTTLE (62332-382-30) November 27, 2018
62332-382-31 62332-382 Alembic Pharmaceuticals Inc. 100 CAPSULE in 1 BOTTLE (62332-382-31) November 27, 2018
62332-382-71 62332-382 Alembic Pharmaceuticals Inc. 500 CAPSULE in 1 BOTTLE (62332-382-71) November 27, 2018
62332-382-90 62332-382 Alembic Pharmaceuticals Inc. 90 CAPSULE in 1 BOTTLE (62332-382-90) November 27, 2018
46708-379-30 46708-379 Alembic Pharmaceuticals Limited 30 CAPSULE in 1 BOTTLE (46708-379-30) November 27, 2018
46708-379-31 46708-379 Alembic Pharmaceuticals Limited 100 CAPSULE in 1 BOTTLE (46708-379-31) November 27, 2018
46708-380-30 46708-380 Alembic Pharmaceuticals Limited 30 CAPSULE in 1 BOTTLE (46708-380-30) November 27, 2018
46708-380-31 46708-380 Alembic Pharmaceuticals Limited 100 CAPSULE in 1 BOTTLE (46708-380-31) November 27, 2018
46708-380-71 46708-380 Alembic Pharmaceuticals Limited 500 CAPSULE in 1 BOTTLE (46708-380-71) November 27, 2018
46708-380-90 46708-380 Alembic Pharmaceuticals Limited 90 CAPSULE in 1 BOTTLE (46708-380-90) November 27, 2018
46708-381-30 46708-381 Alembic Pharmaceuticals Limited 30 CAPSULE in 1 BOTTLE (46708-381-30) November 27, 2018
46708-382-30 46708-382 Alembic Pharmaceuticals Limited 30 CAPSULE in 1 BOTTLE (46708-382-30) November 27, 2018
46708-382-31 46708-382 Alembic Pharmaceuticals Limited 100 CAPSULE in 1 BOTTLE (46708-382-31) November 27, 2018
46708-382-71 46708-382 Alembic Pharmaceuticals Limited 500 CAPSULE in 1 BOTTLE (46708-382-71) November 27, 2018
46708-382-90 46708-382 Alembic Pharmaceuticals Limited 90 CAPSULE in 1 BOTTLE (46708-382-90) November 27, 2018
68084-549-21 68084-549 American Health Packaging 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11) August 1, 2012
65162-556-03 65162-556 Amneal Pharmaceuticals LLC 30 CAPSULE in 1 BOTTLE (65162-556-03) May 23, 2016
65162-556-10 65162-556 Amneal Pharmaceuticals LLC 100 CAPSULE in 1 BOTTLE (65162-556-10) May 23, 2016
65162-556-11 65162-556 Amneal Pharmaceuticals LLC 1000 CAPSULE in 1 BOTTLE (65162-556-11) May 23, 2016
65162-556-50 65162-556 Amneal Pharmaceuticals LLC 500 CAPSULE in 1 BOTTLE (65162-556-50) May 23, 2016
65162-557-03 65162-557 Amneal Pharmaceuticals LLC 30 CAPSULE in 1 BOTTLE (65162-557-03) May 23, 2016
65162-557-10 65162-557 Amneal Pharmaceuticals LLC 100 CAPSULE in 1 BOTTLE (65162-557-10) May 23, 2016
65162-557-11 65162-557 Amneal Pharmaceuticals LLC 1000 CAPSULE in 1 BOTTLE (65162-557-11) May 23, 2016
65162-557-50 65162-557 Amneal Pharmaceuticals LLC 500 CAPSULE in 1 BOTTLE (65162-557-50) May 23, 2016
65162-583-03 65162-583 Amneal Pharmaceuticals LLC 30 CAPSULE in 1 BOTTLE (65162-583-03) May 23, 2016
65162-583-10 65162-583 Amneal Pharmaceuticals LLC 100 CAPSULE in 1 BOTTLE (65162-583-10) May 23, 2016
65162-583-11 65162-583 Amneal Pharmaceuticals LLC 1000 CAPSULE in 1 BOTTLE (65162-583-11) May 23, 2016
65162-583-50 65162-583 Amneal Pharmaceuticals LLC 500 CAPSULE in 1 BOTTLE (65162-583-50) May 23, 2016
65162-584-03 65162-584 Amneal Pharmaceuticals LLC 30 CAPSULE in 1 BOTTLE (65162-584-03) May 23, 2016
65162-584-10 65162-584 Amneal Pharmaceuticals LLC 100 CAPSULE in 1 BOTTLE (65162-584-10) May 23, 2016
65162-584-11 65162-584 Amneal Pharmaceuticals LLC 1000 CAPSULE in 1 BOTTLE (65162-584-11) May 23, 2016
65162-584-50 65162-584 Amneal Pharmaceuticals LLC 500 CAPSULE in 1 BOTTLE (65162-584-50) May 23, 2016
53746-556-01 53746-556 Amneal Pharmaceuticals of New York LLC 100 CAPSULE in 1 BOTTLE (53746-556-01) February 19, 2024
53746-556-05 53746-556 Amneal Pharmaceuticals of New York LLC 500 CAPSULE in 1 BOTTLE (53746-556-05) February 19, 2024
53746-557-01 53746-557 Amneal Pharmaceuticals of New York LLC 100 CAPSULE in 1 BOTTLE (53746-557-01) February 19, 2024
53746-557-05 53746-557 Amneal Pharmaceuticals of New York LLC 500 CAPSULE in 1 BOTTLE (53746-557-05) February 19, 2024
43353-260-15 43353-260 Aphena Pharma Solutions - Tennessee, LLC 15 CAPSULE in 1 BOTTLE (43353-260-15) November 18, 2016
43353-260-20 43353-260 Aphena Pharma Solutions - Tennessee, LLC 20 CAPSULE in 1 BOTTLE (43353-260-20) December 28, 2018
43353-260-28 43353-260 Aphena Pharma Solutions - Tennessee, LLC 28 CAPSULE in 1 BOTTLE (43353-260-28) July 18, 2018
43353-260-30 43353-260 Aphena Pharma Solutions - Tennessee, LLC 30 CAPSULE in 1 BOTTLE (43353-260-30) May 1, 2017
43353-260-53 43353-260 Aphena Pharma Solutions - Tennessee, LLC 60 CAPSULE in 1 BOTTLE (43353-260-53) November 18, 2016
43353-260-60 43353-260 Aphena Pharma Solutions - Tennessee, LLC 90 CAPSULE in 1 BOTTLE (43353-260-60) October 25, 2017
43353-312-10 43353-312 Aphena Pharma Solutions - Tennessee, LLC 10 CAPSULE in 1 BOTTLE (43353-312-10) June 27, 2018
43353-312-15 43353-312 Aphena Pharma Solutions - Tennessee, LLC 15 CAPSULE in 1 BOTTLE (43353-312-15) September 21, 2017
43353-312-28 43353-312 Aphena Pharma Solutions - Tennessee, LLC 28 CAPSULE in 1 BOTTLE (43353-312-28) June 27, 2018
43353-312-30 43353-312 Aphena Pharma Solutions - Tennessee, LLC 30 CAPSULE in 1 BOTTLE (43353-312-30) May 1, 2017
43353-312-45 43353-312 Aphena Pharma Solutions - Tennessee, LLC 45 CAPSULE in 1 BOTTLE (43353-312-45) September 21, 2017
43353-312-53 43353-312 Aphena Pharma Solutions - Tennessee, LLC 60 CAPSULE in 1 BOTTLE (43353-312-53) May 1, 2017
43353-312-60 43353-312 Aphena Pharma Solutions - Tennessee, LLC 90 CAPSULE in 1 BOTTLE (43353-312-60) May 1, 2017
67544-136-10 67544-136 Aphena Pharma Solutions - Tennessee, LLC 10 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-10) August 26, 2004
67544-136-14 67544-136 Aphena Pharma Solutions - Tennessee, LLC 14 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-14) August 26, 2004
67544-136-15 67544-136 Aphena Pharma Solutions - Tennessee, LLC 15 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-15) September 16, 2004
67544-136-20 67544-136 Aphena Pharma Solutions - Tennessee, LLC 20 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-20) September 1, 2004
67544-136-28 67544-136 Aphena Pharma Solutions - Tennessee, LLC 28 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-28) August 30, 2009
67544-136-30 67544-136 Aphena Pharma Solutions - Tennessee, LLC 30 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-30) October 16, 2004
67544-136-45 67544-136 Aphena Pharma Solutions - Tennessee, LLC 45 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-45) September 1, 2004
67544-136-53 67544-136 Aphena Pharma Solutions - Tennessee, LLC 60 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-53) October 16, 2004
67544-136-60 67544-136 Aphena Pharma Solutions - Tennessee, LLC 90 CAPSULE in 1 BOTTLE, PLASTIC (67544-136-60) December 8, 2004
71610-004-30 71610-004 Aphena Pharma Solutions - Tennessee, LLC 30 CAPSULE in 1 BOTTLE (71610-004-30) August 14, 2017
71610-004-53 71610-004 Aphena Pharma Solutions - Tennessee, LLC 60 CAPSULE in 1 BOTTLE (71610-004-53) November 22, 2017
71610-004-60 71610-004 Aphena Pharma Solutions - Tennessee, LLC 90 CAPSULE in 1 BOTTLE (71610-004-60) November 22, 2017
71610-625-10 71610-625 Aphena Pharma Solutions - Tennessee, LLC 10 CAPSULE in 1 BOTTLE (71610-625-10) June 14, 2024
71610-625-15 71610-625 Aphena Pharma Solutions - Tennessee, LLC 15 CAPSULE in 1 BOTTLE (71610-625-15) December 10, 2021
71610-625-20 71610-625 Aphena Pharma Solutions - Tennessee, LLC 20 CAPSULE in 1 BOTTLE (71610-625-20) June 14, 2024
71610-625-28 71610-625 Aphena Pharma Solutions - Tennessee, LLC 28 CAPSULE in 1 BOTTLE (71610-625-28) June 14, 2024
71610-625-30 71610-625 Aphena Pharma Solutions - Tennessee, LLC 30 CAPSULE in 1 BOTTLE (71610-625-30) December 10, 2021
71610-625-45 71610-625 Aphena Pharma Solutions - Tennessee, LLC 45 CAPSULE in 1 BOTTLE (71610-625-45) December 10, 2021
71610-625-53 71610-625 Aphena Pharma Solutions - Tennessee, LLC 60 CAPSULE in 1 BOTTLE (71610-625-53) December 10, 2021
71610-625-60 71610-625 Aphena Pharma Solutions - Tennessee, LLC 90 CAPSULE in 1 BOTTLE (71610-625-60) December 10, 2021
71610-626-15 71610-626 Aphena Pharma Solutions - Tennessee, LLC 15 CAPSULE in 1 BOTTLE (71610-626-15) December 10, 2021
71610-626-28 71610-626 Aphena Pharma Solutions - Tennessee, LLC 28 CAPSULE in 1 BOTTLE (71610-626-28) March 7, 2024
71610-626-30 71610-626 Aphena Pharma Solutions - Tennessee, LLC 30 CAPSULE in 1 BOTTLE (71610-626-30) December 10, 2021
71610-626-53 71610-626 Aphena Pharma Solutions - Tennessee, LLC 60 CAPSULE in 1 BOTTLE (71610-626-53) December 10, 2021
71610-626-60 71610-626 Aphena Pharma Solutions - Tennessee, LLC 90 CAPSULE in 1 BOTTLE (71610-626-60) February 29, 2024
71610-986-28 71610-986 Aphena Pharma Solutions - Tennessee, LLC 28 CAPSULE in 1 BOTTLE (71610-986-28) February 9, 2026
71610-986-30 71610-986 Aphena Pharma Solutions - Tennessee, LLC 30 CAPSULE in 1 BOTTLE (71610-986-30) February 9, 2026
71610-986-60 71610-986 Aphena Pharma Solutions - Tennessee, LLC 90 CAPSULE in 1 BOTTLE (71610-986-60) February 9, 2026
67877-146-01 67877-146 Ascend Laboratories, LLC 100 CAPSULE in 1 BOTTLE (67877-146-01) April 21, 1987
67877-146-05 67877-146 Ascend Laboratories, LLC 500 CAPSULE in 1 BOTTLE (67877-146-05) April 21, 1987
67877-147-01 67877-147 Ascend Laboratories, LLC 100 CAPSULE in 1 BOTTLE (67877-147-01) April 21, 1987
67877-147-05 67877-147 Ascend Laboratories, LLC 500 CAPSULE in 1 BOTTLE (67877-147-05) April 21, 1987
67877-148-01 67877-148 Ascend Laboratories, LLC 100 CAPSULE in 1 BOTTLE (67877-148-01) June 28, 2012
67877-148-05 67877-148 Ascend Laboratories, LLC 500 CAPSULE in 1 BOTTLE (67877-148-05) June 28, 2012
67877-148-30 67877-148 Ascend Laboratories, LLC 30 CAPSULE in 1 BOTTLE (67877-148-30) June 28, 2012
67877-149-01 67877-149 Ascend Laboratories, LLC 100 CAPSULE in 1 BOTTLE (67877-149-01) June 28, 2012
67877-149-05 67877-149 Ascend Laboratories, LLC 500 CAPSULE in 1 BOTTLE (67877-149-05) June 28, 2012
67877-149-30 67877-149 Ascend Laboratories, LLC 30 CAPSULE in 1 BOTTLE (67877-149-30) June 28, 2012
76420-472-01 76420-472 Asclemed USA, Inc. 100 CAPSULE in 1 BOTTLE (76420-472-01) September 18, 2025
76420-472-05 76420-472 Asclemed USA, Inc. 500 CAPSULE in 1 BOTTLE (76420-472-05) September 18, 2025
76420-472-30 76420-472 Asclemed USA, Inc. 30 CAPSULE in 1 BOTTLE (76420-472-30) September 18, 2025
76420-472-60 76420-472 Asclemed USA, Inc. 60 CAPSULE in 1 BOTTLE (76420-472-60) September 18, 2025
76420-472-90 76420-472 Asclemed USA, Inc. 90 CAPSULE in 1 BOTTLE (76420-472-90) September 18, 2025
76420-473-01 76420-473 Asclemed USA, Inc. 100 CAPSULE in 1 BOTTLE (76420-473-01) September 18, 2025
76420-473-05 76420-473 Asclemed USA, Inc. 500 CAPSULE in 1 BOTTLE (76420-473-05) September 18, 2025
76420-473-30 76420-473 Asclemed USA, Inc. 30 CAPSULE in 1 BOTTLE (76420-473-30) September 18, 2025
76420-473-60 76420-473 Asclemed USA, Inc. 60 CAPSULE in 1 BOTTLE (76420-473-60) September 18, 2025
76420-473-90 76420-473 Asclemed USA, Inc. 90 CAPSULE in 1 BOTTLE (76420-473-90) September 18, 2025
76420-474-01 76420-474 Asclemed USA, Inc. 100 CAPSULE in 1 BOTTLE (76420-474-01) September 18, 2025
76420-474-05 76420-474 Asclemed USA, Inc. 500 CAPSULE in 1 BOTTLE (76420-474-05) September 18, 2025
76420-474-30 76420-474 Asclemed USA, Inc. 30 CAPSULE in 1 BOTTLE (76420-474-30) September 18, 2025
76420-474-60 76420-474 Asclemed USA, Inc. 60 CAPSULE in 1 BOTTLE (76420-474-60) September 18, 2025
76420-474-90 76420-474 Asclemed USA, Inc. 90 CAPSULE in 1 BOTTLE (76420-474-90) September 18, 2025
76420-475-01 76420-475 Asclemed USA, Inc. 100 CAPSULE in 1 BOTTLE (76420-475-01) September 18, 2025
76420-475-05 76420-475 Asclemed USA, Inc. 500 CAPSULE in 1 BOTTLE (76420-475-05) September 18, 2025
76420-475-30 76420-475 Asclemed USA, Inc. 30 CAPSULE in 1 BOTTLE (76420-475-30) September 18, 2025
76420-475-60 76420-475 Asclemed USA, Inc. 60 CAPSULE in 1 BOTTLE (76420-475-60) September 18, 2025
76420-475-90 76420-475 Asclemed USA, Inc. 90 CAPSULE in 1 BOTTLE (76420-475-90) September 18, 2025
50268-779-15 50268-779 AvPAK 50 BLISTER PACK in 1 BOX (50268-779-15) / 1 CAPSULE in 1 BLISTER PACK (50268-779-11) October 19, 2023
50268-780-13 50268-780 AvPAK 30 BLISTER PACK in 1 BOX (50268-780-13) / 1 CAPSULE in 1 BLISTER PACK (50268-780-11) October 19, 2023
63629-1057-1 63629-1057 Bryant Ranch Prepack 500 CAPSULE in 1 BOTTLE (63629-1057-1) December 21, 2021
63629-1619-1 63629-1619 Bryant Ranch Prepack 20 CAPSULE in 1 BOTTLE (63629-1619-1) June 11, 2010
63629-1619-2 63629-1619 Bryant Ranch Prepack 30 CAPSULE in 1 BOTTLE (63629-1619-2) October 10, 2006
63629-1619-3 63629-1619 Bryant Ranch Prepack 60 CAPSULE in 1 BOTTLE (63629-1619-3) July 28, 2006
63629-1619-4 63629-1619 Bryant Ranch Prepack 90 CAPSULE in 1 BOTTLE (63629-1619-4) September 15, 2008
63629-1619-5 63629-1619 Bryant Ranch Prepack 28 CAPSULE in 1 BOTTLE (63629-1619-5) April 29, 2010
63629-1619-6 63629-1619 Bryant Ranch Prepack 120 CAPSULE in 1 BOTTLE (63629-1619-6) September 9, 2026
63629-1619-7 63629-1619 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (63629-1619-7) September 9, 2026
63629-1621-1 63629-1621 Bryant Ranch Prepack 30 CAPSULE in 1 BOTTLE (63629-1621-1) October 18, 2005
63629-1621-2 63629-1621 Bryant Ranch Prepack 20 CAPSULE in 1 BOTTLE (63629-1621-2) October 3, 2019
63629-1621-3 63629-1621 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (63629-1621-3) April 22, 2010
63629-1621-4 63629-1621 Bryant Ranch Prepack 60 CAPSULE in 1 BOTTLE (63629-1621-4) July 18, 2006
63629-1621-5 63629-1621 Bryant Ranch Prepack 90 CAPSULE in 1 BOTTLE (63629-1621-5) January 15, 2013
63629-1621-6 63629-1621 Bryant Ranch Prepack 28 CAPSULE in 1 BOTTLE (63629-1621-6) March 22, 2010
63629-1621-7 63629-1621 Bryant Ranch Prepack 10 CAPSULE in 1 BOTTLE (63629-1621-7) September 9, 2026
63629-1621-8 63629-1621 Bryant Ranch Prepack 45 CAPSULE in 1 BOTTLE (63629-1621-8) September 9, 2026
63629-1621-9 63629-1621 Bryant Ranch Prepack 120 CAPSULE in 1 BOTTLE (63629-1621-9) September 9, 2026
63629-8601-1 63629-8601 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (63629-8601-1) July 13, 2021
63629-8602-1 63629-8602 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (63629-8602-1) July 13, 2021
63629-8603-1 63629-8603 Bryant Ranch Prepack 500 CAPSULE in 1 BOTTLE (63629-8603-1) July 13, 2021
63629-8604-1 63629-8604 Bryant Ranch Prepack 30 CAPSULE in 1 BOTTLE (63629-8604-1) July 13, 2021
63629-8605-1 63629-8605 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (63629-8605-1) July 13, 2021
63629-8606-1 63629-8606 Bryant Ranch Prepack 500 CAPSULE in 1 BOTTLE (63629-8606-1) July 13, 2021
71335-0315-1 71335-0315 Bryant Ranch Prepack 20 CAPSULE in 1 BOTTLE (71335-0315-1) June 21, 2018
71335-0315-2 71335-0315 Bryant Ranch Prepack 30 CAPSULE in 1 BOTTLE (71335-0315-2) March 6, 2018
71335-0315-3 71335-0315 Bryant Ranch Prepack 60 CAPSULE in 1 BOTTLE (71335-0315-3) February 19, 2018
71335-0315-4 71335-0315 Bryant Ranch Prepack 90 CAPSULE in 1 BOTTLE (71335-0315-4) April 20, 2018
71335-0315-5 71335-0315 Bryant Ranch Prepack 28 CAPSULE in 1 BOTTLE (71335-0315-5) December 27, 2021
71335-0315-6 71335-0315 Bryant Ranch Prepack 120 CAPSULE in 1 BOTTLE (71335-0315-6) December 27, 2021
71335-0315-7 71335-0315 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (71335-0315-7) December 27, 2021
71335-1901-1 71335-1901 Bryant Ranch Prepack 30 CAPSULE in 1 BOTTLE (71335-1901-1) July 15, 2021
71335-1901-2 71335-1901 Bryant Ranch Prepack 20 CAPSULE in 1 BOTTLE (71335-1901-2) December 11, 2024
71335-1901-3 71335-1901 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (71335-1901-3) December 11, 2024
71335-1901-4 71335-1901 Bryant Ranch Prepack 60 CAPSULE in 1 BOTTLE (71335-1901-4) August 26, 2021
71335-1901-5 71335-1901 Bryant Ranch Prepack 90 CAPSULE in 1 BOTTLE (71335-1901-5) November 3, 2021
71335-1901-6 71335-1901 Bryant Ranch Prepack 28 CAPSULE in 1 BOTTLE (71335-1901-6) December 11, 2024
71335-1901-7 71335-1901 Bryant Ranch Prepack 10 CAPSULE in 1 BOTTLE (71335-1901-7) December 11, 2024
71335-1901-8 71335-1901 Bryant Ranch Prepack 45 CAPSULE in 1 BOTTLE (71335-1901-8) December 11, 2024
71335-1901-9 71335-1901 Bryant Ranch Prepack 120 CAPSULE in 1 BOTTLE (71335-1901-9) December 11, 2024
71335-2043-1 71335-2043 Bryant Ranch Prepack 30 CAPSULE in 1 BOTTLE (71335-2043-1) February 10, 2022
71335-2302-1 71335-2302 Bryant Ranch Prepack 500 CAPSULE in 1 BOTTLE (71335-2302-1) December 1, 2023
71335-2900-1 71335-2900 Bryant Ranch Prepack 500 CAPSULE in 1 BOTTLE (71335-2900-1) November 6, 2025
71335-2910-1 71335-2910 Bryant Ranch Prepack 500 CAPSULE in 1 BOTTLE (71335-2910-1) November 6, 2025
71335-2965-1 71335-2965 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (71335-2965-1) November 6, 2025
71335-9741-1 71335-9741 Bryant Ranch Prepack 20 CAPSULE in 1 BOTTLE (71335-9741-1) July 10, 2023
71335-9741-2 71335-9741 Bryant Ranch Prepack 30 CAPSULE in 1 BOTTLE (71335-9741-2) July 10, 2023
71335-9741-3 71335-9741 Bryant Ranch Prepack 60 CAPSULE in 1 BOTTLE (71335-9741-3) July 10, 2023
71335-9741-4 71335-9741 Bryant Ranch Prepack 90 CAPSULE in 1 BOTTLE (71335-9741-4) July 10, 2023
71335-9741-5 71335-9741 Bryant Ranch Prepack 28 CAPSULE in 1 BOTTLE (71335-9741-5) July 10, 2023
71335-9741-6 71335-9741 Bryant Ranch Prepack 120 CAPSULE in 1 BOTTLE (71335-9741-6) July 10, 2023
71335-9741-7 71335-9741 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (71335-9741-7) July 10, 2023
72162-1824-1 72162-1824 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (72162-1824-1) March 7, 2024
72162-1824-5 72162-1824 Bryant Ranch Prepack 500 CAPSULE in 1 BOTTLE (72162-1824-5) March 7, 2024
72162-1825-1 72162-1825 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (72162-1825-1) January 11, 2024
72162-1825-5 72162-1825 Bryant Ranch Prepack 500 CAPSULE in 1 BOTTLE (72162-1825-5) January 11, 2024
72162-1826-1 72162-1826 Bryant Ranch Prepack 100 CAPSULE in 1 BOTTLE (72162-1826-1) March 6, 2024
72162-1827-3 72162-1827 Bryant Ranch Prepack 30 CAPSULE in 1 BOTTLE (72162-1827-3) March 7, 2024
51407-507-05 51407-507 Golden State Medical Supply, Inc. 500 CAPSULE in 1 BOTTLE (51407-507-05) June 5, 2024
51407-508-05 51407-508 Golden State Medical Supply, Inc. 500 CAPSULE in 1 BOTTLE (51407-508-05) June 5, 2024
0904-6436-04 0904-6436 Major Pharmaceuticals 30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACK March 25, 2015
66267-321-30 66267-321 NuCare Pharmaceuticals,Inc. 30 CAPSULE in 1 BOTTLE (66267-321-30) January 17, 2018
68071-4083-3 68071-4083 NuCare Pharmaceuticals,Inc. 30 CAPSULE in 1 BOTTLE (68071-4083-3) December 29, 2017
55289-196-01 55289-196 PD-Rx Pharmaceuticals, Inc. 100 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-01) February 5, 2016
55289-196-14 55289-196 PD-Rx Pharmaceuticals, Inc. 14 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-14) February 5, 2016
55289-196-30 55289-196 PD-Rx Pharmaceuticals, Inc. 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-30) February 5, 2016
55289-196-60 55289-196 PD-Rx Pharmaceuticals, Inc. 60 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-60) February 5, 2016
55289-196-82 55289-196 PD-Rx Pharmaceuticals, Inc. 500 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-82) April 20, 2020
55289-196-90 55289-196 PD-Rx Pharmaceuticals, Inc. 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-196-90) December 13, 2018
55289-660-01 55289-660 PD-Rx Pharmaceuticals, Inc. 100 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-01) January 21, 2016
55289-660-30 55289-660 PD-Rx Pharmaceuticals, Inc. 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-30) January 21, 2016
55289-660-60 55289-660 PD-Rx Pharmaceuticals, Inc. 60 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-60) January 21, 2016
55289-660-82 55289-660 PD-Rx Pharmaceuticals, Inc. 500 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-82) April 20, 2020
55289-660-90 55289-660 PD-Rx Pharmaceuticals, Inc. 90 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-90) January 21, 2016
72789-449-30 72789-449 PD-Rx Pharmaceuticals, Inc. 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-449-30) November 6, 2024
68788-8081-3 68788-8081 Preferred Pharmaceuticals Inc. 30 CAPSULE in 1 BOTTLE (68788-8081-3) October 5, 2021
68788-8139-3 68788-8139 Preferred Pharmaceuticals Inc. 30 CAPSULE in 1 BOTTLE (68788-8139-3) February 11, 2022
68788-8493-3 68788-8493 Preferred Pharmaceuticals Inc. 30 CAPSULE in 1 BOTTLE (68788-8493-3) July 24, 2023
63187-132-30 63187-132 Proficient Rx LP 30 CAPSULE in 1 BOTTLE (63187-132-30) January 1, 2019
63187-132-60 63187-132 Proficient Rx LP 60 CAPSULE in 1 BOTTLE (63187-132-60) June 8, 2023
63187-132-90 63187-132 Proficient Rx LP 90 CAPSULE in 1 BOTTLE (63187-132-90) June 8, 2023
63187-497-00 63187-497 Proficient Rx LP 100 CAPSULE in 1 BOTTLE (63187-497-00) January 1, 2019
63187-497-30 63187-497 Proficient Rx LP 30 CAPSULE in 1 BOTTLE (63187-497-30) January 1, 2019
63187-497-60 63187-497 Proficient Rx LP 60 CAPSULE in 1 BOTTLE (63187-497-60) January 1, 2019
63187-497-90 63187-497 Proficient Rx LP 90 CAPSULE in 1 BOTTLE (63187-497-90) January 1, 2019
71205-914-00 71205-914 Proficient Rx LP 100 CAPSULE in 1 BOTTLE (71205-914-00) July 14, 2021
71205-914-30 71205-914 Proficient Rx LP 30 CAPSULE in 1 BOTTLE (71205-914-30) July 14, 2021
71205-914-55 71205-914 Proficient Rx LP 500 CAPSULE in 1 BOTTLE (71205-914-55) July 14, 2021
71205-914-60 71205-914 Proficient Rx LP 60 CAPSULE in 1 BOTTLE (71205-914-60) July 14, 2021
71205-914-72 71205-914 Proficient Rx LP 120 CAPSULE in 1 BOTTLE (71205-914-72) July 14, 2021
71205-914-90 71205-914 Proficient Rx LP 90 CAPSULE in 1 BOTTLE (71205-914-90) July 14, 2021
71205-915-00 71205-915 Proficient Rx LP 100 CAPSULE in 1 BOTTLE (71205-915-00) July 14, 2021
71205-915-30 71205-915 Proficient Rx LP 30 CAPSULE in 1 BOTTLE (71205-915-30) July 14, 2021
71205-915-55 71205-915 Proficient Rx LP 500 CAPSULE in 1 BOTTLE (71205-915-55) July 14, 2021
71205-915-60 71205-915 Proficient Rx LP 60 CAPSULE in 1 BOTTLE (71205-915-60) July 14, 2021
71205-915-72 71205-915 Proficient Rx LP 120 CAPSULE in 1 BOTTLE (71205-915-72) July 14, 2021
71205-915-90 71205-915 Proficient Rx LP 90 CAPSULE in 1 BOTTLE (71205-915-90) July 14, 2021
70518-0647-0 70518-0647 REMEDYREPACK INC. 30 CAPSULE in 1 BLISTER PACK (70518-0647-0) July 28, 2017
70518-2487-2 70518-2487 REMEDYREPACK INC. 30 CAPSULE in 1 BLISTER PACK (70518-2487-2) August 13, 2025
43547-611-10 43547-611 Solco Healthcare U.S., LLC 100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10) January 5, 2023
43547-612-10 43547-612 Solco Healthcare U.S., LLC 100 CAPSULE in 1 BOTTLE, PLASTIC (43547-612-10) January 5, 2023
43547-612-50 43547-612 Solco Healthcare U.S., LLC 500 CAPSULE in 1 BOTTLE, PLASTIC (43547-612-50) January 5, 2023
43547-613-03 43547-613 Solco Healthcare U.S., LLC 30 CAPSULE in 1 BOTTLE, PLASTIC (43547-613-03) January 5, 2023
43547-614-10 43547-614 Solco Healthcare U.S., LLC 100 CAPSULE in 1 BOTTLE, PLASTIC (43547-614-10) January 5, 2023
43547-614-50 43547-614 Solco Healthcare U.S., LLC 500 CAPSULE in 1 BOTTLE, PLASTIC (43547-614-50) January 5, 2023
0406-9959-03 0406-9959 SpecGx LLC 30 CAPSULE in 1 BOTTLE (0406-9959-03) February 23, 2010
0406-9960-01 0406-9960 SpecGx LLC 100 CAPSULE in 1 BOTTLE (0406-9960-01) February 23, 2010
0406-9961-01 0406-9961 SpecGx LLC 100 CAPSULE in 1 BOTTLE (0406-9961-01) February 23, 2010
0406-9962-01 0406-9962 SpecGx LLC 100 CAPSULE in 1 BOTTLE (0406-9962-01) February 23, 2010
50090-0186 50090-0186 A-S Medication Solutions — April 21, 1987
50090-0285 50090-0285 A-S Medication Solutions — April 21, 1987
0228-2076 0228-2076 Actavis Pharma, Inc. — September 30, 1990
0228-2077 0228-2077 Actavis Pharma, Inc. — September 30, 1990
80425-0191 80425-0191 Advanced Rx Pharmacy of Tennessee, LLC — June 14, 2022
80425-0295 80425-0295 Advanced Rx Pharmacy of Tennessee, LLC — April 4, 2023
62332-379 62332-379 Alembic Pharmaceuticals Inc. — November 27, 2018
62332-380 62332-380 Alembic Pharmaceuticals Inc. — November 27, 2018
62332-381 62332-381 Alembic Pharmaceuticals Inc. — November 27, 2018
62332-382 62332-382 Alembic Pharmaceuticals Inc. — November 27, 2018
46708-379 46708-379 Alembic Pharmaceuticals Limited — November 27, 2018
46708-380 46708-380 Alembic Pharmaceuticals Limited — November 27, 2018
46708-381 46708-381 Alembic Pharmaceuticals Limited — November 27, 2018
46708-382 46708-382 Alembic Pharmaceuticals Limited — November 27, 2018
68084-549 68084-549 American Health Packaging — August 1, 2012
65162-556 65162-556 Amneal Pharmaceuticals LLC — May 23, 2016
65162-557 65162-557 Amneal Pharmaceuticals LLC — May 23, 2016
65162-583 65162-583 Amneal Pharmaceuticals LLC — May 23, 2016
65162-584 65162-584 Amneal Pharmaceuticals LLC — May 23, 2016
53746-556 53746-556 Amneal Pharmaceuticals of New York LLC — February 19, 2024
53746-557 53746-557 Amneal Pharmaceuticals of New York LLC — February 19, 2024
43353-260 43353-260 Aphena Pharma Solutions - Tennessee, LLC — April 21, 1987
43353-312 43353-312 Aphena Pharma Solutions - Tennessee, LLC — April 21, 1987
67544-136 67544-136 Aphena Pharma Solutions - Tennessee, LLC — August 3, 1987
71610-004 71610-004 Aphena Pharma Solutions - Tennessee, LLC — February 23, 2010
71610-625 71610-625 Aphena Pharma Solutions - Tennessee, LLC — February 23, 2010
71610-626 71610-626 Aphena Pharma Solutions - Tennessee, LLC — February 23, 2010
71610-986 71610-986 Aphena Pharma Solutions - Tennessee, LLC — November 23, 2018
67877-146 67877-146 Ascend Laboratories, LLC — April 21, 1987
67877-147 67877-147 Ascend Laboratories, LLC — April 21, 1987
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50268-779 50268-779 AvPAK — October 19, 2023
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63629-1057 63629-1057 Bryant Ranch Prepack — April 21, 1987
63629-1619 63629-1619 Bryant Ranch Prepack — April 21, 1987
63629-1621 63629-1621 Bryant Ranch Prepack — April 21, 1987
63629-8601 63629-8601 Bryant Ranch Prepack — June 28, 2012
63629-8602 63629-8602 Bryant Ranch Prepack — April 21, 1987
63629-8603 63629-8603 Bryant Ranch Prepack — April 21, 1987
63629-8604 63629-8604 Bryant Ranch Prepack — June 28, 2012
63629-8605 63629-8605 Bryant Ranch Prepack — April 21, 1987
63629-8606 63629-8606 Bryant Ranch Prepack — April 21, 1987
71335-0315 71335-0315 Bryant Ranch Prepack — September 30, 1990
71335-1901 71335-1901 Bryant Ranch Prepack — May 23, 2016
71335-2043 71335-2043 Bryant Ranch Prepack — November 27, 2018
71335-2302 71335-2302 Bryant Ranch Prepack — April 21, 1987
71335-2900 71335-2900 Bryant Ranch Prepack — April 21, 1987
71335-2910 71335-2910 Bryant Ranch Prepack — April 21, 1987
71335-2965 71335-2965 Bryant Ranch Prepack — April 21, 1987
71335-9741 71335-9741 Bryant Ranch Prepack — November 27, 2018
72162-1824 72162-1824 Bryant Ranch Prepack — April 21, 1987
72162-1825 72162-1825 Bryant Ranch Prepack — April 21, 1987
72162-1826 72162-1826 Bryant Ranch Prepack — June 28, 2012
72162-1827 72162-1827 Bryant Ranch Prepack — June 28, 2012
51407-507 51407-507 Golden State Medical Supply, Inc. — November 23, 2018
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0904-6436 0904-6436 Major Pharmaceuticals — March 25, 2015
66267-321 66267-321 NuCare Pharmaceuticals,Inc. — April 21, 1987
68071-4083 68071-4083 NuCare Pharmaceuticals,Inc. — September 30, 1990
55289-196 55289-196 PD-Rx Pharmaceuticals, Inc. — April 21, 1987
55289-660 55289-660 PD-Rx Pharmaceuticals, Inc. — April 21, 1987
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68788-8081 68788-8081 Preferred Pharmaceuticals Inc. — October 5, 2021
68788-8139 68788-8139 Preferred Pharmaceuticals Inc. — February 11, 2022
68788-8493 68788-8493 Preferred Pharmaceuticals Inc. — July 24, 2023
63187-132 63187-132 Proficient Rx LP — April 21, 1987
63187-497 63187-497 Proficient Rx LP — April 21, 1987
71205-914 71205-914 Proficient Rx LP — April 21, 1987
71205-915 71205-915 Proficient Rx LP — April 21, 1987
70518-0647 70518-0647 REMEDYREPACK INC. — July 28, 2017
70518-2487 70518-2487 REMEDYREPACK INC. — December 16, 2019
43547-611 43547-611 Solco Healthcare U.S., LLC — January 5, 2023
43547-612 43547-612 Solco Healthcare U.S., LLC — January 5, 2023
43547-613 43547-613 Solco Healthcare U.S., LLC — January 5, 2023
43547-614 43547-614 Solco Healthcare U.S., LLC — January 5, 2023
0406-9959 0406-9959 SpecGx LLC — February 23, 2010
0406-9960 0406-9960 SpecGx LLC — February 23, 2010
0406-9961 0406-9961 SpecGx LLC — February 23, 2010
0406-9962 0406-9962 SpecGx LLC — February 23, 2010

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

Generated September 25, 2026 · 11 sections on this page.