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Metronidazole
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Nitroimidazole Antimicrobial [EPC] | EPC | All 15 members |
| Nitroimidazoles [CS] | CS | All 15 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 206560-001 | METRONIDAZOLE | TABLET | METRONIDAZOLE | Prescription | AB | ||
| 206560-002 | METRONIDAZOLE | TABLET | METRONIDAZOLE | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat 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| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 10 | Labeling | Approved | November 5, 2024 | Standard |
| Supplement | 9 | Labeling | Approved | July 8, 2024 | Standard |
| Supplement | 8 | Labeling | Approved | June 18, 2024 | Standard |
| Supplement | 6 | Labeling | Approved | August 15, 2023 | Standard |
| Supplement | 3 | Labeling | Approved | August 19, 2021 | Standard |
| Supplement | 2 | Labeling | Approved | August 13, 2019 | Standard |
| Original application | 1 | Approved | November 16, 2016 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260501). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS ). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Symptomatic Trichomoniasis Metronidazole tablets, USP are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis Metronidazole tablets, USP are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets, USP in cases of reinfection. Amebiasis Metronidazole tablets, USP are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole tablets, USP therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections Metronidazole tablets, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets, USP therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets, USP. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis , B. distasonis , B. ovatus , B. thetaiotaomicron , B. vulgatus ), Clostridium species , Eubacterium species, Peptococcus species , and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets, USP and other antibacterial drugs, metronidazole tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility infor …
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Trichomoniasis: In the Female: One-day treatment − two grams of metronidazole tablets, given either as a single dose or in two divided doses of one gram each, given in the same day. Seven-day course of treatment - 250 mg three times daily for seven consecutive days. There is some indication from controlled comparative studies that cure rates as determined by vaginal smears and signs and symptoms, may be higher after a seven-day course of treatment than after a one-day treatment regimen. The dosage regimen should be individualized. Single-dose treatment can assure compliance, especially if administered under supervision, in those patients who cannot be relied on to continue the seven-day regimen. A seven-day course of treatment may minimize reinfection by protecting the patient long enough for the sexual contacts to obtain appropriate treatment. Further, some patients may tolerate one treatment regimen better than the other. Pregnant patients should not be treated during the first trimester (see CONTRAINDICATIONS ). In pregnant patients for whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation (see PRECAUTIONS , Pregnancy ). When repeat courses of the drug are required, it is recommended that an interval of four to six weeks elapse between courses and that the presence of the trichomonad be reconfirmed by appropriate laboratory measures. Total and differential leukocyte counts should be made before and after re-treatment. In the Male: Treatment should be individualized as it is for the female. Amebiasis Adults: For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days. For amebic liver abscess: 500 mg or 750 mg orally three times daily for 5 to 10 days. Pediatric patients: 35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days. Anaerobic Bacterial Infections In the treatment of most serious anaerobic infections, intravenous metronidazole is usually administered initially. The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70-kg adult). A maximum of 4 g should not be exceeded during a 24-hour period. The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment. Dosage Adjustments Patients with Severe Hepatic Impairment For patients with severe hepatic impairment (Child-Pugh C), the dose of metronidazole tablets should be reduced by 50% (see CLINICAL PHARMACOLOGY and PRECAUTIONS ). Patients Undergoing Hemodialysis: Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of metronidazole cannot be separated from the hemodialysis session, supplementation of metronidazole dosage following the hemodialysis session should be considered, depending on the patient’s clinical situation (see CLINICAL PHARMACOLOGY ).
Dosage Adjustments Patients with Severe Hepatic Impairment For patients with severe hepatic impairment (Child-Pugh C), the dose of metronidazole tablets should be reduced by 50% (see CLINICAL PHARMACOLOGY and PRECAUTIONS ). Patients Undergoing Hemodialysis: Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of metronidazole cannot be separated from the hemodialysis session, supplementation of metronidazole dosage following the hemodialysis session should be considered, depending on the patient’s clinical situation (see CLINICAL PHARMACOLOGY ).
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Hypersensitivity Metronidazole tablets are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. In patients with trichomoniasis, metronidazole tablets are contraindicated during the first trimester of pregnancy (see PRECAUTIONS ). Psychotic Reaction with Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see PRECAUTIONS , Drug Interactions ). Interaction with Alcohol Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see PRECAUTIONS , Drug Interactions ). Cockayne Syndrome Metronidazole Tablets are contraindicated in patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne syndrome (see ADVERSE REACTIONS ).
Hypersensitivity Metronidazole tablets are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. In patients with trichomoniasis, metronidazole tablets are contraindicated during the first trimester of pregnancy (see PRECAUTIONS ).
Psychotic Reaction with Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see PRECAUTIONS , Drug Interactions ).
Interaction with Alcohol Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing. Discontinue consumption of alcohol or products containing propylene glycol during and for at least three days after therapy with metronidazole (see PRECAUTIONS , Drug Interactions ). Cockayne Syndrome Metronidazole Tablets are contraindicated in patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne syndrome (see ADVERSE REACTIONS ).
Warnings
openFDA Drug LabelingWARNINGS Central and Peripheral Nervous System Effects Encephalopathy and peripheral neuropathy: Cases of encephalopathy and peripheral neuropathy (including optic neuropathy) have been reported with metronidazole. Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. CNS lesions seen on MRI have been described in reports of encephalopathy. CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible. Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity. Convulsive seizures have been reported in patients treated with metronidazole. Aseptic meningitis: Cases of aseptic meningitis have been reported with metronidazole. Symptoms can occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued. The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy (see ADVERSE REACTIONS). Risk of Hepatotoxicity and Death in Patients with Cockayne Syndrome Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use. In this population, metronidazole should therefore be used after careful benefit-risk assessment and only if no alternative treatment is available. Obtain liver function tests prior to the start of therapy, within the first 2-3 days after initiation of therapy, frequently during therapy and after end of treatment. Discontinue metronidazole if elevation of liver function tests occurs, and monitor liver function tests until the baseline values are reached. Advise patients with Cockayne syndrome to stop taking metronidazole immediately if they experience any symptoms of potential liver injury, such as abdominal pain, nausea, change in stool color or jaundice, and to contact their healthcare provider.
Central and Peripheral Nervous System Effects Encephalopathy and peripheral neuropathy: Cases of encephalopathy and peripheral neuropathy (including optic neuropathy) have been reported with metronidazole. Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. CNS lesions seen on MRI have been described in reports of encephalopathy. CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible. Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity. Convulsive seizures have been reported in patients treated with metronidazole. Aseptic meningitis: Cases of aseptic meningitis have been reported with metronidazole. Symptoms can occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued. The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy (see ADVERSE REACTIONS).
Risk of Hepatotoxicity and Death in Patients with Cockayne Syndrome Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use. In this population, metronidazole should therefore be used after careful benefit-risk assessment and only if no alternative treatment is available. Obtain liver function tests prior to the start of therapy, within the first 2-3 days after initiation of therapy, frequently during therapy and after end of treatment. Discontinue metronidaz …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS The following reactions have been reported during treatment with metronidazole: Central Nervous System: The most serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur. In addition, patients have reported headache, syncope, dizziness, vertigo, incoordination, ataxia, tinnitus, hearing impairment, hearing loss, confusion, dysarthria, irritability, depression, weakness, and insomnia (see WARNINGS ). Gastrointestinal: The most common adverse reactions reported have been referable to the gastrointestinal tract, particularly nausea, sometimes accompanied by headache, anorexia, and occasionally vomiting; diarrhea; epigastric distress; and abdominal cramping and constipation. Mouth : A sharp, unpleasant metallic taste is not unusual. Furry tongue, glossitis, and stomatitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy. Dermatologic: Dermatitis bullous, fixed drug eruption, erythematous rash and pruritus. Hematopoietic : Reversible neutropenia (leukopenia); rarely, reversible thrombocytopenia. Cardiovascular : QT prolongation has been reported, particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval. Flattening of the T-wave may be seen in electrocardiographic tracings. Hypersensitivity : Toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) (see WARNINGS ), urticaria, erythematous rash, flushing, nasal congestion, dryness of the mouth (or vagina or vulva), and fever. Renal : Dysuria, cystitis, polyuria, incontinence, and a sense of pelvic pressure. Instances of darkened urine have been reported by approximately one patient in 100,000. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of metronidazole and seems to have no clinical significance. Hepatic : Cases of severe irreversible hepatotoxicity/acute liver failure, including cases with fatal outcomes with very rapid onset after initiation of systemic use of metronidazole, have been reported in patients with Cockayne syndrome (latency from drug start to signs of liver failure as short as 2 days) (see CONTRAINDICATIONS ). Other : Proliferation of Candida in the vagina, dyspareunia, decrease of libido, proctitis, and fleeting joint pains sometimes resembling “serum sickness.” Rare cases of pancreatitis, which generally abated on withdrawal of the drug, have been reported. Patients with Crohn’s disease are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohn’s disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause and effect relationship has not been established. Crohn’s disease is not an approved indication for metronidazole tablets. To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Drug Interactions
openFDA Drug LabelingDrug Interactions Disulfiram Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole should not be given to patients who have taken disulfiram within the last two weeks (see CONTRAINDICATIONS ). Alcoholic Beverages Abdominal cramps, nausea, vomiting, headaches, and flushing may occur if alcoholic beverages or products containing propylene glycol are consumed during or following metronidazole therapy (see CONTRAINDICATIONS ). Warfarin and other Oral Anticoagulants Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. When metronidazole is prescribed for patients on this type of anticoagulant therapy, prothrombin time and INR should be carefully monitored. Lithium In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine levels should be obtained several days after beginning metronidazole to detect any increase that may precede clinical symptoms of lithium intoxication. Busulfan Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Metronidazole should not be administered concomitantly with busulfan unless the benefit outweighs the risk. If no therapeutic alternatives to metronidazole are available, and concomitant administration with busulfan is medically needed, frequent monitoring of busulfan plasma concentration should be performed and the busulfan dose should be adjusted accordingly. Drugs that Inhibit CYP450 Enzymes The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole. Drugs that Induce CYP450 Enzymes The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported. Drugs that Prolong the QT interval QT prolongation has been reported, particularly when metronidazole was administered with drugs with the potential for prolonging the QT interval.
Disulfiram Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole should not be given to patients who have taken disulfiram within the last two weeks (see CONTRAINDICATIONS ).
Alcoholic Beverages Abdominal cramps, nausea, vomiting, headaches, and flushing may occur if alcoholic beverages or products containing propylene glycol are consumed during or following metronidazole therapy (see CONTRAINDICATIONS ).
Warfarin and other Oral Anticoagulants Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. When metronidazole is prescribed for patients on this type of anticoagulant therapy, prothrombin time and INR should be carefully monitored.
Lithium In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine levels should be obtained several days after beginning metronidazole to detect any increase that may precede clinical symptoms of lithium intoxication.
Busulfan Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Metronidazole should not be administered concomitantly with busulfan unless the benefit outweighs the risk. If no therapeutic alternatives to metronidazole ar …
Description
openFDA Drug LabelingDESCRIPTION Metronidazole tablets, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula: Metronidazole USP is a white to pale yellow, crystalline powder. It is sparingly soluble in water and alcohol; slightly soluble in ether and chloroform; soluble in dilute hydrochloric acid. Each metronidazole tablet, USP intended for oral administration contains 250 mg or 500 mg of metronidazole. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose and stearic acid. Additionally, each tablet contains opadry II white 02F580003 which contains hypromellose, polyethylene glycol, talc and titanium dioxide. figure
Overdosage
openFDA Drug LabelingOVERDOSAGE Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia. Oral metronidazole has been studied as a radiation sensitizer in the treatment of malignant tumors. Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day. Treatment of Overdosage : There is no specific antidote for metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Metronidazole Tablets USP, 250 mg are white to off-white, round, biconvex, film coated tablets debossed with '850' on one side and plain on other side and are supplied as follows: NDC 76420-800-21 in bottles of 21 tablets (repackaged from NDC 72578-007-XX) NDC 76420-800-30 in bottles of 30 tablets (repackaged from NDC 72578-007-XX) NDC 76420-800-60 in bottles of 60 tablets (repackaged from NDC 72578-007-XX) NDC 76420-800-90 in bottles of 90 tablets (repackaged from NDC 72578-007-XX) NDC 76420-800-01 in bottles of 100 tablets (relabeled from NDC 72578-007-01) NDC 76420-800-25 in bottles of 250 tablets (relabeled from NDC 72578-007-21) NDC 76420-800-05 in bottles of 500 tablets (relabeled from NDC 72578-007-05) Metronidazole Tablets USP, 500 mg are white to off-white, oval shaped, biconvex, film coated tablets debossed with '851' on one side and plain on other side and are supplied as follows: NDC 76420-801-21 in bottles of 21 tablets (repackaged from NDC 72578-008-XX) NDC 76420-801-30 in bottles of 30 tablets (repackaged from NDC 72578-008-XX) NDC 76420-801-60 in bottles of 60 tablets (repackaged from NDC 72578-008-XX) NDC 76420-801-90 in bottles of 90 tablets (repackaged from NDC 72578-008-XX) NDC 76420-801-50 in bottles of 50 tablets (relabeled from NDC 72578-008-18) NDC 76420-801-01 in bottles of 100 tablets (relabeled from NDC 72578-008-01) NDC 76420-801-05 in bottles of 500 tablets (relabeled from NDC 72578-008-05) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Protect from light. Dispense in a tight, light-resistant container (USP). Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: METRONIDAZOLE. 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.
Shortages
Source: FDA Drug Shortages| Status | Availability | Company | Presentation | Updated |
|---|---|---|---|---|
| Current | Available | Baxter Healthcare | Flagyl I.v. Rtu In Plastic Container, Injection, 500 mg/100 mL (NDC 0338-1055-48) | September 17, 2026 |
| Current | Limited Availability | InfoRLife SA | Metronidazole in Flexible Container, Injection, 500 mg/100 mL (NDC 0409-0152-24) | August 18, 2026 |
| Current | Limited Availability | InfoRLife SA | Metronidazole, Injection, 500 mg/100 mL (NDC 25021-131-82) | August 18, 2026 |
| Current | Unavailable | Gland Pharma Limited | Metronidazole In Plastic Container, Injection, 500 mg/100 mL (NDC 47335-993-01) | July 22, 2026 |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-5691-0 | 50090-5691 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-5691-0) | September 21, 2021 |
| 50090-5691-1 | 50090-5691 | A-S Medication Solutions | 28 TABLET in 1 BOTTLE (50090-5691-1) | September 21, 2021 |
| 50090-5691-2 | 50090-5691 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-5691-2) | September 21, 2021 |
| 69292-207-01 | 69292-207 | AMICI PHARMA INC | 100 TABLET in 1 BOTTLE (69292-207-01) | August 26, 2019 |
| 69292-207-50 | 69292-207 | AMICI PHARMA INC | 500 TABLET in 1 BOTTLE (69292-207-50) | August 26, 2019 |
| 69292-208-01 | 69292-208 | AMICI PHARMA INC | 100 TABLET in 1 BOTTLE (69292-208-01) | November 22, 2019 |
| 69292-208-50 | 69292-208 | AMICI PHARMA INC | 500 TABLET in 1 BOTTLE (69292-208-50) | November 22, 2019 |
| 15955-388-01 | 15955-388 | Alembic Labs LLC | 100 TABLET in 1 BOTTLE (15955-388-01) | June 26, 2019 |
| 15955-388-05 | 15955-388 | Alembic Labs LLC | 500 TABLET in 1 BOTTLE (15955-388-05) | June 26, 2019 |
| 15955-389-01 | 15955-389 | Alembic Labs LLC | 100 TABLET in 1 BOTTLE (15955-389-01) | June 26, 2019 |
| 15955-389-05 | 15955-389 | Alembic Labs LLC | 500 TABLET in 1 BOTTLE (15955-389-05) | June 26, 2019 |
| 62332-016-30 | 62332-016 | Alembic Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (62332-016-30) | December 1, 2016 |
| 62332-016-31 | 62332-016 | Alembic Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (62332-016-31) | December 1, 2016 |
| 62332-016-50 | 62332-016 | Alembic Pharmaceuticals Inc. | 50 TABLET in 1 BOTTLE (62332-016-50) | December 1, 2016 |
| 62332-016-61 | 62332-016 | Alembic Pharmaceuticals Inc. | 250 TABLET in 1 BOTTLE (62332-016-61) | December 1, 2016 |
| 62332-016-71 | 62332-016 | Alembic Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (62332-016-71) | December 1, 2016 |
| 62332-016-91 | 62332-016 | Alembic Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (62332-016-91) | December 1, 2016 |
| 62332-017-30 | 62332-017 | Alembic Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (62332-017-30) | December 1, 2016 |
| 62332-017-31 | 62332-017 | Alembic Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (62332-017-31) | December 1, 2016 |
| 62332-017-50 | 62332-017 | Alembic Pharmaceuticals Inc. | 50 TABLET in 1 BOTTLE (62332-017-50) | December 1, 2016 |
| 62332-017-71 | 62332-017 | Alembic Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (62332-017-71) | December 1, 2016 |
| 62332-017-91 | 62332-017 | Alembic Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (62332-017-91) | December 1, 2016 |
| 46708-428-30 | 46708-428 | Alembic Pharmaceuticals Limited | 30 TABLET in 1 BOTTLE (46708-428-30) | December 1, 2016 |
| 46708-428-31 | 46708-428 | Alembic Pharmaceuticals Limited | 100 TABLET in 1 BOTTLE (46708-428-31) | December 1, 2016 |
| 46708-428-50 | 46708-428 | Alembic Pharmaceuticals Limited | 50 TABLET in 1 BOTTLE (46708-428-50) | December 1, 2016 |
| 46708-428-61 | 46708-428 | Alembic Pharmaceuticals Limited | 250 TABLET in 1 BOTTLE (46708-428-61) | December 1, 2016 |
| 46708-428-71 | 46708-428 | Alembic Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (46708-428-71) | December 1, 2016 |
| 46708-428-91 | 46708-428 | Alembic Pharmaceuticals Limited | 1000 TABLET in 1 BOTTLE (46708-428-91) | December 1, 2016 |
| 46708-429-30 | 46708-429 | Alembic Pharmaceuticals Limited | 30 TABLET in 1 BOTTLE (46708-429-30) | December 1, 2016 |
| 46708-429-31 | 46708-429 | Alembic Pharmaceuticals Limited | 100 TABLET in 1 BOTTLE (46708-429-31) | December 1, 2016 |
| 46708-429-50 | 46708-429 | Alembic Pharmaceuticals Limited | 50 TABLET in 1 BOTTLE (46708-429-50) | December 1, 2016 |
| 46708-429-71 | 46708-429 | Alembic Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (46708-429-71) | December 1, 2016 |
| 46708-429-91 | 46708-429 | Alembic Pharmaceuticals Limited | 1000 TABLET in 1 BOTTLE (46708-429-91) | December 1, 2016 |
| 60687-526-01 | 60687-526 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-526-01) / 1 TABLET in 1 BLISTER PACK (60687-526-11) | April 9, 2020 |
| 60687-550-01 | 60687-550 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-550-01) / 1 TABLET in 1 BLISTER PACK (60687-550-11) | March 20, 2020 |
| 76420-800-01 | 76420-800 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE (76420-800-01) | April 26, 2024 |
| 76420-800-05 | 76420-800 | Asclemed USA, Inc. | 500 TABLET in 1 BOTTLE (76420-800-05) | April 26, 2024 |
| 76420-800-21 | 76420-800 | Asclemed USA, Inc. | 21 TABLET in 1 BOTTLE (76420-800-21) | April 26, 2024 |
| 76420-800-25 | 76420-800 | Asclemed USA, Inc. | 250 TABLET in 1 BOTTLE (76420-800-25) | April 26, 2024 |
| 76420-800-30 | 76420-800 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-800-30) | April 26, 2024 |
| 76420-800-60 | 76420-800 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE (76420-800-60) | April 26, 2024 |
| 76420-800-90 | 76420-800 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE (76420-800-90) | April 26, 2024 |
| 76420-801-01 | 76420-801 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE (76420-801-01) | April 26, 2024 |
| 76420-801-05 | 76420-801 | Asclemed USA, Inc. | 500 TABLET in 1 BOTTLE (76420-801-05) | April 26, 2024 |
| 76420-801-21 | 76420-801 | Asclemed USA, Inc. | 21 TABLET in 1 BOTTLE (76420-801-21) | April 26, 2024 |
| 76420-801-30 | 76420-801 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-801-30) | April 26, 2024 |
| 76420-801-50 | 76420-801 | Asclemed USA, Inc. | 50 TABLET in 1 BOTTLE (76420-801-50) | April 26, 2024 |
| 76420-801-60 | 76420-801 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE (76420-801-60) | April 26, 2024 |
| 76420-801-90 | 76420-801 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE (76420-801-90) | April 26, 2024 |
| 65862-694-01 | 65862-694 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (65862-694-01) | May 29, 2015 |
| 65862-694-05 | 65862-694 | Aurobindo Pharma Limited | 500 TABLET in 1 BOTTLE (65862-694-05) | May 29, 2015 |
| 65862-694-25 | 65862-694 | Aurobindo Pharma Limited | 250 TABLET in 1 BOTTLE (65862-694-25) | May 29, 2015 |
| 65862-694-50 | 65862-694 | Aurobindo Pharma Limited | 50 TABLET in 1 BOTTLE (65862-694-50) | May 29, 2015 |
| 65862-694-99 | 65862-694 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-694-99) | May 29, 2015 |
| 65862-695-01 | 65862-695 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (65862-695-01) | May 29, 2015 |
| 65862-695-05 | 65862-695 | Aurobindo Pharma Limited | 500 TABLET in 1 BOTTLE (65862-695-05) | May 29, 2015 |
| 65862-695-50 | 65862-695 | Aurobindo Pharma Limited | 50 TABLET in 1 BOTTLE (65862-695-50) | May 29, 2015 |
| 65862-695-99 | 65862-695 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-695-99) | May 29, 2015 |
| 50268-534-15 | 50268-534 | AvPAK | 50 BLISTER PACK in 1 BOX (50268-534-15) / 1 TABLET in 1 BLISTER PACK (50268-534-11) | October 30, 2019 |
| 50268-535-15 | 50268-535 | AvPAK | 50 BLISTER PACK in 1 BOX (50268-535-15) / 1 TABLET in 1 BLISTER PACK (50268-535-11) | October 30, 2019 |
| 63629-1386-0 | 63629-1386 | Bryant Ranch Prepack | 40 TABLET in 1 BOTTLE (63629-1386-0) | August 3, 2010 |
| 63629-1386-1 | 63629-1386 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (63629-1386-1) | December 16, 2004 |
| 63629-1386-2 | 63629-1386 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-1386-2) | December 20, 2004 |
| 63629-1386-3 | 63629-1386 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (63629-1386-3) | March 26, 2007 |
| 63629-1386-4 | 63629-1386 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (63629-1386-4) | August 10, 2006 |
| 63629-1386-5 | 63629-1386 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (63629-1386-5) | February 12, 2009 |
| 63629-1386-6 | 63629-1386 | Bryant Ranch Prepack | 4 TABLET in 1 BOTTLE (63629-1386-6) | June 12, 2008 |
| 63629-1386-7 | 63629-1386 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (63629-1386-7) | July 7, 2008 |
| 63629-1386-8 | 63629-1386 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-1386-8) | August 26, 2010 |
| 63629-1386-9 | 63629-1386 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (63629-1386-9) | March 8, 2022 |
| 71335-0858-0 | 71335-0858 | Bryant Ranch Prepack | 7 TABLET in 1 BOTTLE (71335-0858-0) | August 9, 2024 |
| 71335-0858-1 | 71335-0858 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (71335-0858-1) | May 13, 2019 |
| 71335-0858-2 | 71335-0858 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0858-2) | December 26, 2019 |
| 71335-0858-3 | 71335-0858 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-0858-3) | August 9, 2024 |
| 71335-0858-4 | 71335-0858 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0858-4) | August 9, 2024 |
| 71335-0858-5 | 71335-0858 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-0858-5) | August 9, 2024 |
| 71335-0858-6 | 71335-0858 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-0858-6) | August 9, 2024 |
| 71335-0858-7 | 71335-0858 | Bryant Ranch Prepack | 40 TABLET in 1 BOTTLE (71335-0858-7) | August 9, 2024 |
| 71335-0858-8 | 71335-0858 | Bryant Ranch Prepack | 42 TABLET in 1 BOTTLE (71335-0858-8) | August 9, 2024 |
| 71335-0858-9 | 71335-0858 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-0858-9) | August 6, 2018 |
| 71335-1681-0 | 71335-1681 | Bryant Ranch Prepack | 40 TABLET in 1 BOTTLE (71335-1681-0) | October 31, 2024 |
| 71335-1681-1 | 71335-1681 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1681-1) | August 5, 2020 |
| 71335-1681-2 | 71335-1681 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1681-2) | August 4, 2020 |
| 71335-1681-3 | 71335-1681 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-1681-3) | August 5, 2020 |
| 71335-1681-4 | 71335-1681 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-1681-4) | October 31, 2024 |
| 71335-1681-5 | 71335-1681 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (71335-1681-5) | August 10, 2020 |
| 71335-1681-6 | 71335-1681 | Bryant Ranch Prepack | 4 TABLET in 1 BOTTLE (71335-1681-6) | July 12, 2021 |
| 71335-1681-7 | 71335-1681 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1681-7) | August 31, 2020 |
| 71335-1681-8 | 71335-1681 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1681-8) | October 31, 2024 |
| 71335-1681-9 | 71335-1681 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1681-9) | October 31, 2024 |
| 71335-1703-0 | 71335-1703 | Bryant Ranch Prepack | 40 TABLET in 1 BOTTLE (71335-1703-0) | November 22, 2022 |
| 71335-1703-1 | 71335-1703 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1703-1) | September 23, 2020 |
| 71335-1703-2 | 71335-1703 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1703-2) | October 20, 2020 |
| 71335-1703-3 | 71335-1703 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-1703-3) | October 5, 2020 |
| 71335-1703-4 | 71335-1703 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-1703-4) | August 12, 2024 |
| 71335-1703-5 | 71335-1703 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (71335-1703-5) | October 16, 2020 |
| 71335-1703-6 | 71335-1703 | Bryant Ranch Prepack | 4 TABLET in 1 BOTTLE (71335-1703-6) | November 5, 2021 |
| 71335-1703-7 | 71335-1703 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1703-7) | September 24, 2020 |
| 71335-1703-8 | 71335-1703 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1703-8) | August 12, 2024 |
| 71335-1703-9 | 71335-1703 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1703-9) | April 15, 2024 |
| 71335-1775-0 | 71335-1775 | Bryant Ranch Prepack | 7 TABLET in 1 BOTTLE (71335-1775-0) | August 12, 2024 |
| 71335-1775-1 | 71335-1775 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (71335-1775-1) | September 6, 2023 |
| 71335-1775-2 | 71335-1775 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1775-2) | March 11, 2021 |
| 71335-1775-3 | 71335-1775 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1775-3) | August 12, 2024 |
| 71335-1775-4 | 71335-1775 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1775-4) | August 12, 2024 |
| 71335-1775-5 | 71335-1775 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1775-5) | October 30, 2023 |
| 71335-1775-6 | 71335-1775 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-1775-6) | April 20, 2021 |
| 71335-1775-7 | 71335-1775 | Bryant Ranch Prepack | 40 TABLET in 1 BOTTLE (71335-1775-7) | August 12, 2024 |
| 71335-1775-8 | 71335-1775 | Bryant Ranch Prepack | 42 TABLET in 1 BOTTLE (71335-1775-8) | August 12, 2024 |
| 71335-1775-9 | 71335-1775 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-1775-9) | February 1, 2021 |
| 71335-1838-0 | 71335-1838 | Bryant Ranch Prepack | 7 TABLET in 1 BOTTLE (71335-1838-0) | October 31, 2024 |
| 71335-1838-1 | 71335-1838 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (71335-1838-1) | November 23, 2021 |
| 71335-1838-2 | 71335-1838 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1838-2) | June 14, 2021 |
| 71335-1838-3 | 71335-1838 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1838-3) | May 14, 2021 |
| 71335-1838-4 | 71335-1838 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1838-4) | October 31, 2024 |
| 71335-1838-5 | 71335-1838 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1838-5) | November 1, 2021 |
| 71335-1838-6 | 71335-1838 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-1838-6) | December 11, 2023 |
| 71335-1838-7 | 71335-1838 | Bryant Ranch Prepack | 40 TABLET in 1 BOTTLE (71335-1838-7) | October 31, 2024 |
| 71335-1838-8 | 71335-1838 | Bryant Ranch Prepack | 42 TABLET in 1 BOTTLE (71335-1838-8) | October 31, 2024 |
| 71335-1838-9 | 71335-1838 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-1838-9) | April 30, 2021 |
| 71335-1922-0 | 71335-1922 | Bryant Ranch Prepack | 40 TABLET in 1 BOTTLE (71335-1922-0) | October 31, 2024 |
| 71335-1922-1 | 71335-1922 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1922-1) | August 11, 2021 |
| 71335-1922-2 | 71335-1922 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1922-2) | August 26, 2021 |
| 71335-1922-3 | 71335-1922 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-1922-3) | October 7, 2021 |
| 71335-1922-4 | 71335-1922 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-1922-4) | October 31, 2024 |
| 71335-1922-5 | 71335-1922 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (71335-1922-5) | December 9, 2021 |
| 71335-1922-6 | 71335-1922 | Bryant Ranch Prepack | 4 TABLET in 1 BOTTLE (71335-1922-6) | October 4, 2021 |
| 71335-1922-7 | 71335-1922 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1922-7) | August 3, 2021 |
| 71335-1922-8 | 71335-1922 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1922-8) | October 31, 2024 |
| 71335-1922-9 | 71335-1922 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1922-9) | October 31, 2024 |
| 71335-2681-1 | 71335-2681 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-2681-1) | September 12, 2025 |
| 71335-2681-2 | 71335-2681 | Bryant Ranch Prepack | 3 TABLET in 1 BOTTLE (71335-2681-2) | September 12, 2025 |
| 71335-2681-3 | 71335-2681 | Bryant Ranch Prepack | 9 TABLET in 1 BOTTLE (71335-2681-3) | September 12, 2025 |
| 71335-2681-4 | 71335-2681 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-2681-4) | September 12, 2025 |
| 71335-2949-1 | 71335-2949 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-2949-1) | October 30, 2025 |
| 72162-2468-2 | 72162-2468 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (72162-2468-2) | March 27, 2025 |
| 72162-2468-5 | 72162-2468 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-2468-5) | April 28, 2025 |
| 55154-2343-0 | 55154-2343 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-2343-0) / 1 TABLET in 1 BLISTER PACK | March 5, 2025 |
| 55154-8190-0 | 55154-8190 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-8190-0) / 1 TABLET in 1 BLISTER PACK | February 20, 2020 |
| 62135-795-90 | 62135-795 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-795-90) | November 7, 2023 |
| 62135-796-90 | 62135-796 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-796-90) | November 7, 2023 |
| 51407-372-01 | 51407-372 | Golden State Medical Supply, Inc. | 100 TABLET in 1 BOTTLE (51407-372-01) | March 31, 2020 |
| 51407-372-05 | 51407-372 | Golden State Medical Supply, Inc. | 500 TABLET in 1 BOTTLE (51407-372-05) | March 31, 2020 |
| 51407-376-01 | 51407-376 | Golden State Medical Supply, Inc. | 100 TABLET in 1 BOTTLE (51407-376-01) | April 16, 2020 |
| 51407-376-05 | 51407-376 | Golden State Medical Supply, Inc. | 500 TABLET in 1 BOTTLE (51407-376-05) | April 16, 2020 |
| 23155-651-01 | 23155-651 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (23155-651-01) | November 29, 2017 |
| 23155-651-05 | 23155-651 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (23155-651-05) | November 29, 2017 |
| 23155-652-01 | 23155-652 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (23155-652-01) | November 29, 2017 |
| 23155-652-05 | 23155-652 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (23155-652-05) | November 29, 2017 |
| 0904-7126-61 | 0904-7126 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7126-61) / 1 TABLET in 1 BLISTER PACK | November 29, 2017 |
| 0904-7156-61 | 0904-7156 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7156-61) / 1 TABLET in 1 BLISTER PACK | November 29, 2017 |
| 58657-739-01 | 58657-739 | Method Pharmaceuticals LLC | 100 TABLET in 1 BOTTLE (58657-739-01) | January 4, 2025 |
| 58657-739-56 | 58657-739 | Method Pharmaceuticals LLC | 56 TABLET in 1 BOTTLE (58657-739-56) | January 4, 2025 |
| 58657-933-01 | 58657-933 | Method Pharmaceuticals LLC | 100 BLISTER PACK in 1 CARTON (58657-933-01) / 1 TABLET in 1 BLISTER PACK (58657-933-10) | July 1, 2025 |
| 58657-933-05 | 58657-933 | Method Pharmaceuticals LLC | 50 BLISTER PACK in 1 CARTON (58657-933-05) / 1 TABLET in 1 BLISTER PACK (58657-933-10) | July 1, 2025 |
| 58657-934-01 | 58657-934 | Method Pharmaceuticals LLC | 100 BLISTER PACK in 1 CARTON (58657-934-01) / 1 TABLET in 1 BLISTER PACK (58657-934-10) | July 1, 2025 |
| 58657-934-05 | 58657-934 | Method Pharmaceuticals LLC | 50 BLISTER PACK in 1 CARTON (58657-934-05) / 1 TABLET in 1 BLISTER PACK (58657-934-10) | July 1, 2025 |
| 58657-939-01 | 58657-939 | Method Pharmaceuticals LLC | 100 BLISTER PACK in 1 CARTON (58657-939-01) / 1 TABLET in 1 BLISTER PACK (58657-939-10) | July 1, 2025 |
| 58657-939-03 | 58657-939 | Method Pharmaceuticals LLC | 30 BLISTER PACK in 1 CARTON (58657-939-03) / 1 TABLET in 1 BLISTER PACK (58657-939-10) | May 4, 2026 |
| 58657-939-05 | 58657-939 | Method Pharmaceuticals LLC | 50 BLISTER PACK in 1 CARTON (58657-939-05) / 1 TABLET in 1 BLISTER PACK (58657-939-10) | July 1, 2025 |
| 51655-441-20 | 51655-441 | Northwind Health Company, LLC | 20 TABLET in 1 BOTTLE, PLASTIC (51655-441-20) | January 19, 2023 |
| 51655-441-21 | 51655-441 | Northwind Health Company, LLC | 21 TABLET in 1 BOTTLE, PLASTIC (51655-441-21) | November 30, 2022 |
| 51655-441-52 | 51655-441 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-441-52) | June 27, 2023 |
| 51655-441-84 | 51655-441 | Northwind Health Company, LLC | 14 TABLET in 1 BOTTLE, PLASTIC (51655-441-84) | January 11, 2023 |
| 51655-974-29 | 51655-974 | Northwind Health Company, LLC | 28 TABLET in 1 BOTTLE, PLASTIC (51655-974-29) | April 3, 2023 |
| 51655-974-52 | 51655-974 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-974-52) | February 28, 2023 |
| 82868-014-14 | 82868-014 | Northwind Health Company, LLC | 14 TABLET in 1 BOTTLE, PLASTIC (82868-014-14) | September 28, 2023 |
| 82868-014-20 | 82868-014 | Northwind Health Company, LLC | 20 TABLET in 1 BOTTLE, PLASTIC (82868-014-20) | August 12, 2024 |
| 82868-014-21 | 82868-014 | Northwind Health Company, LLC | 21 TABLET in 1 BOTTLE, PLASTIC (82868-014-21) | February 5, 2024 |
| 82868-014-28 | 82868-014 | Northwind Health Company, LLC | 28 TABLET in 1 BOTTLE, PLASTIC (82868-014-28) | October 4, 2023 |
| 82868-014-30 | 82868-014 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (82868-014-30) | November 30, 2023 |
| 68071-2251-6 | 68071-2251 | NuCare Pharmaceuticals,Inc. | 6 TABLET in 1 BOTTLE, PLASTIC (68071-2251-6) | August 31, 2020 |
| 68071-2288-4 | 68071-2288 | NuCare Pharmaceuticals,Inc. | 4 TABLET in 1 BOTTLE (68071-2288-4) | October 28, 2020 |
| 68071-2399-4 | 68071-2399 | NuCare Pharmaceuticals,Inc. | 4 TABLET in 1 BOTTLE (68071-2399-4) | May 12, 2021 |
| 68071-2399-6 | 68071-2399 | NuCare Pharmaceuticals,Inc. | 6 TABLET in 1 BOTTLE (68071-2399-6) | May 12, 2021 |
| 68071-2409-1 | 68071-2409 | NuCare Pharmaceuticals,Inc. | 4 TABLET in 1 BOTTLE (68071-2409-1) | May 21, 2021 |
| 68071-2409-2 | 68071-2409 | NuCare Pharmaceuticals,Inc. | 21 TABLET in 1 BOTTLE (68071-2409-2) | May 21, 2021 |
| 68071-2409-3 | 68071-2409 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-2409-3) | May 21, 2021 |
| 68071-2409-4 | 68071-2409 | NuCare Pharmaceuticals,Inc. | 14 TABLET in 1 BOTTLE (68071-2409-4) | May 21, 2021 |
| 68071-2409-5 | 68071-2409 | NuCare Pharmaceuticals,Inc. | 40 TABLET in 1 BOTTLE (68071-2409-5) | May 21, 2021 |
| 68071-2409-7 | 68071-2409 | NuCare Pharmaceuticals,Inc. | 20 TABLET in 1 BOTTLE (68071-2409-7) | May 21, 2021 |
| 68071-2409-8 | 68071-2409 | NuCare Pharmaceuticals,Inc. | 28 TABLET in 1 BOTTLE (68071-2409-8) | May 21, 2021 |
| 68071-2409-9 | 68071-2409 | NuCare Pharmaceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-2409-9) | May 21, 2021 |
| 68071-5073-2 | 68071-5073 | NuCare Pharmaceuticals,Inc. | 21 TABLET in 1 BOTTLE (68071-5073-2) | September 26, 2019 |
| 68071-5283-8 | 68071-5283 | NuCare Pharmaceuticals,Inc. | 28 TABLET in 1 BOTTLE, PLASTIC (68071-5283-8) | June 18, 2020 |
| 72789-007-04 | 72789-007 | PD-Rx Pharmaceuticals, Inc. | 4 TABLET in 1 BOTTLE, PLASTIC (72789-007-04) | December 16, 2019 |
| 72789-007-06 | 72789-007 | PD-Rx Pharmaceuticals, Inc. | 6 TABLET in 1 BOTTLE, PLASTIC (72789-007-06) | October 30, 2023 |
| 72789-007-09 | 72789-007 | PD-Rx Pharmaceuticals, Inc. | 9 TABLET in 1 BOTTLE, PLASTIC (72789-007-09) | October 9, 2019 |
| 72789-007-14 | 72789-007 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET in 1 BOTTLE, PLASTIC (72789-007-14) | September 13, 2019 |
| 72789-007-21 | 72789-007 | PD-Rx Pharmaceuticals, Inc. | 21 TABLET in 1 BOTTLE, PLASTIC (72789-007-21) | September 26, 2019 |
| 72789-007-28 | 72789-007 | PD-Rx Pharmaceuticals, Inc. | 28 TABLET in 1 BOTTLE, PLASTIC (72789-007-28) | June 4, 2020 |
| 72789-007-30 | 72789-007 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-007-30) | November 21, 2019 |
| 72789-007-79 | 72789-007 | PD-Rx Pharmaceuticals, Inc. | 1 TABLET in 1 BOTTLE, PLASTIC (72789-007-79) | November 7, 2019 |
| 72789-011-04 | 72789-011 | PD-Rx Pharmaceuticals, Inc. | 4 TABLET in 1 BOTTLE, PLASTIC (72789-011-04) | August 20, 2019 |
| 72789-011-14 | 72789-011 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET in 1 BOTTLE, PLASTIC (72789-011-14) | January 13, 2020 |
| 72789-195-06 | 72789-195 | PD-Rx Pharmaceuticals, Inc. | 6 TABLET in 1 BOTTLE, PLASTIC (72789-195-06) | October 29, 2021 |
| 72789-195-21 | 72789-195 | PD-Rx Pharmaceuticals, Inc. | 21 TABLET in 1 BOTTLE, PLASTIC (72789-195-21) | June 30, 2021 |
| 72789-195-30 | 72789-195 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-195-30) | June 30, 2021 |
| 68788-7815-1 | 68788-7815 | Preferred Pharmaceuticals Inc. | 14 TABLET in 1 BOTTLE (68788-7815-1) | November 13, 2020 |
| 68788-7815-2 | 68788-7815 | Preferred Pharmaceuticals Inc. | 21 TABLET in 1 BOTTLE (68788-7815-2) | November 13, 2020 |
| 68788-7815-3 | 68788-7815 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-7815-3) | November 13, 2020 |
| 68788-7815-4 | 68788-7815 | Preferred Pharmaceuticals Inc. | 28 TABLET in 1 BOTTLE (68788-7815-4) | November 13, 2020 |
| 68788-7815-5 | 68788-7815 | Preferred Pharmaceuticals Inc. | 56 TABLET in 1 BOTTLE (68788-7815-5) | November 13, 2020 |
| 68788-7815-7 | 68788-7815 | Preferred Pharmaceuticals Inc. | 42 TABLET in 1 BOTTLE (68788-7815-7) | November 13, 2020 |
| 63187-035-04 | 63187-035 | Proficient Rx LP | 4 TABLET in 1 BOTTLE (63187-035-04) | December 14, 2021 |
| 63187-035-14 | 63187-035 | Proficient Rx LP | 14 TABLET in 1 BOTTLE (63187-035-14) | November 1, 2018 |
| 63187-035-21 | 63187-035 | Proficient Rx LP | 21 TABLET in 1 BOTTLE (63187-035-21) | November 1, 2018 |
| 63187-035-28 | 63187-035 | Proficient Rx LP | 28 TABLET in 1 BOTTLE (63187-035-28) | August 23, 2024 |
| 63187-035-30 | 63187-035 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-035-30) | November 1, 2018 |
| 63187-511-14 | 63187-511 | Proficient Rx LP | 14 TABLET in 1 BOTTLE (63187-511-14) | August 12, 2021 |
| 63187-511-21 | 63187-511 | Proficient Rx LP | 21 TABLET in 1 BOTTLE (63187-511-21) | August 12, 2021 |
| 63187-511-28 | 63187-511 | Proficient Rx LP | 28 TABLET in 1 BOTTLE (63187-511-28) | August 12, 2021 |
| 63187-511-30 | 63187-511 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-511-30) | August 12, 2021 |
| 63187-511-60 | 63187-511 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (63187-511-60) | August 12, 2021 |
| 63187-511-90 | 63187-511 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-511-90) | August 12, 2021 |
| 70518-0013-0 | 70518-0013 | REMEDYREPACK INC. | 28 TABLET in 1 BOTTLE, PLASTIC (70518-0013-0) | November 23, 2016 |
| 70518-1240-0 | 70518-1240 | REMEDYREPACK INC. | 4 TABLET in 1 BOTTLE, PLASTIC (70518-1240-0) | June 1, 2018 |
| 70518-1240-1 | 70518-1240 | REMEDYREPACK INC. | 14 TABLET in 1 BOTTLE, PLASTIC (70518-1240-1) | June 1, 2018 |
| 70518-1241-0 | 70518-1241 | REMEDYREPACK INC. | 14 TABLET in 1 BOTTLE, PLASTIC (70518-1241-0) | June 1, 2018 |
| 70518-1241-2 | 70518-1241 | REMEDYREPACK INC. | 30 TABLET in 1 BOTTLE, PLASTIC (70518-1241-2) | September 24, 2021 |
| 70518-2663-0 | 70518-2663 | REMEDYREPACK INC. | 4 TABLET in 1 BOTTLE, PLASTIC (70518-2663-0) | March 30, 2020 |
| 70518-2663-4 | 70518-2663 | REMEDYREPACK INC. | 14 TABLET in 1 BOTTLE, PLASTIC (70518-2663-4) | November 8, 2021 |
| 70518-2663-5 | 70518-2663 | REMEDYREPACK INC. | 4 TABLET in 1 BOTTLE, PLASTIC (70518-2663-5) | August 31, 2022 |
| 70518-2663-7 | 70518-2663 | REMEDYREPACK INC. | 4 TABLET in 1 BOTTLE, PLASTIC (70518-2663-7) | October 24, 2022 |
| 70518-3042-2 | 70518-3042 | REMEDYREPACK INC. | 28 TABLET in 1 BLISTER PACK (70518-3042-2) | December 5, 2022 |
| 70518-3042-3 | 70518-3042 | REMEDYREPACK INC. | 28 TABLET in 1 BOTTLE, PLASTIC (70518-3042-3) | March 25, 2025 |
| 70518-3110-5 | 70518-3110 | REMEDYREPACK INC. | 14 TABLET in 1 BOTTLE, PLASTIC (70518-3110-5) | September 30, 2024 |
| 70518-3265-1 | 70518-3265 | REMEDYREPACK INC. | 4 TABLET in 1 BOTTLE, PLASTIC (70518-3265-1) | February 10, 2022 |
| 70518-3265-2 | 70518-3265 | REMEDYREPACK INC. | 14 TABLET in 1 BOTTLE, PLASTIC (70518-3265-2) | April 17, 2022 |
| 70518-3265-4 | 70518-3265 | REMEDYREPACK INC. | 20 TABLET in 1 BOTTLE, PLASTIC (70518-3265-4) | October 3, 2025 |
| 70518-3265-5 | 70518-3265 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3265-5) | December 20, 2025 |
| 67296-0078-1 | 67296-0078 | Redpharm Drug, inc. | 30 TABLET in 1 BOTTLE (67296-0078-1) | September 30, 1990 |
| 67296-0078-3 | 67296-0078 | Redpharm Drug, inc. | 21 TABLET in 1 BOTTLE (67296-0078-3) | September 30, 1990 |
| 67296-0078-4 | 67296-0078 | Redpharm Drug, inc. | 20 TABLET in 1 BOTTLE (67296-0078-4) | September 30, 1990 |
| 16571-664-01 | 16571-664 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (16571-664-01) | May 29, 2015 |
| 16571-664-50 | 16571-664 | Rising Pharma Holdings, Inc. | 500 TABLET in 1 BOTTLE (16571-664-50) | May 29, 2015 |
| 16571-665-01 | 16571-665 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (16571-665-01) | May 29, 2015 |
| 16571-665-50 | 16571-665 | Rising Pharma Holdings, Inc. | 500 TABLET in 1 BOTTLE (16571-665-50) | May 29, 2015 |
| 60760-539-14 | 60760-539 | ST. MARY'S MEDICAL PARK PHARMACY | 14 TABLET in 1 BOTTLE, PLASTIC (60760-539-14) | June 17, 2022 |
| 85766-024-01 | 85766-024 | Sportpharm LLC | 100 TABLET in 1 BOTTLE (85766-024-01) | August 5, 2025 |
| 85766-024-05 | 85766-024 | Sportpharm LLC | 500 TABLET in 1 BOTTLE (85766-024-05) | August 5, 2025 |
| 85766-024-14 | 85766-024 | Sportpharm LLC | 14 TABLET in 1 BOTTLE (85766-024-14) | August 5, 2025 |
| 85766-024-20 | 85766-024 | Sportpharm LLC | 20 TABLET in 1 BOTTLE (85766-024-20) | August 5, 2025 |
| 85766-024-30 | 85766-024 | Sportpharm LLC | 30 TABLET in 1 BOTTLE (85766-024-30) | August 5, 2025 |
| 85766-024-50 | 85766-024 | Sportpharm LLC | 50 TABLET in 1 BOTTLE (85766-024-50) | August 5, 2025 |
| 85766-024-60 | 85766-024 | Sportpharm LLC | 60 TABLET in 1 BOTTLE (85766-024-60) | August 5, 2025 |
| 85766-024-90 | 85766-024 | Sportpharm LLC | 90 TABLET in 1 BOTTLE (85766-024-90) | August 5, 2025 |
| 50111-333-01 | 50111-333 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (50111-333-01) | September 30, 1990 |
| 50111-333-02 | 50111-333 | Teva Pharmaceuticals USA, Inc. | 500 TABLET in 1 BOTTLE (50111-333-02) | September 30, 1990 |
| 50111-333-06 | 50111-333 | Teva Pharmaceuticals USA, Inc. | 250 TABLET in 1 BOTTLE (50111-333-06) | September 30, 1990 |
| 50111-334-01 | 50111-334 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (50111-334-01) | September 30, 1990 |
| 50111-334-02 | 50111-334 | Teva Pharmaceuticals USA, Inc. | 500 TABLET in 1 BOTTLE (50111-334-02) | September 30, 1990 |
| 72578-007-01 | 72578-007 | Viona Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (72578-007-01) | February 23, 2019 |
| 72578-007-05 | 72578-007 | Viona Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (72578-007-05) | February 23, 2019 |
| 72578-007-21 | 72578-007 | Viona Pharmaceuticals Inc | 250 TABLET in 1 BOTTLE (72578-007-21) | February 23, 2019 |
| 72578-008-01 | 72578-008 | Viona Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (72578-008-01) | February 23, 2019 |
| 72578-008-05 | 72578-008 | Viona Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (72578-008-05) | February 23, 2019 |
| 72578-008-18 | 72578-008 | Viona Pharmaceuticals Inc | 50 TABLET in 1 BOTTLE (72578-008-18) | February 23, 2019 |
| 70771-1045-1 | 70771-1045 | Zydus Lifesciences Limited | 100 TABLET in 1 BOTTLE (70771-1045-1) | February 23, 2019 |
| 70771-1045-5 | 70771-1045 | Zydus Lifesciences Limited | 500 TABLET in 1 BOTTLE (70771-1045-5) | February 23, 2019 |
| 70771-1045-8 | 70771-1045 | Zydus Lifesciences Limited | 250 TABLET in 1 BOTTLE (70771-1045-8) | February 23, 2019 |
| 70771-1046-1 | 70771-1046 | Zydus Lifesciences Limited | 100 TABLET in 1 BOTTLE (70771-1046-1) | February 23, 2019 |
| 70771-1046-5 | 70771-1046 | Zydus Lifesciences Limited | 500 TABLET in 1 BOTTLE (70771-1046-5) | February 23, 2019 |
| 70771-1046-7 | 70771-1046 | Zydus Lifesciences Limited | 50 TABLET in 1 BOTTLE (70771-1046-7) | February 23, 2019 |
| 50090-5691 | 50090-5691 | A-S Medication Solutions | — | May 29, 2015 |
| 69292-207 | 69292-207 | AMICI PHARMA INC | — | August 26, 2019 |
| 69292-208 | 69292-208 | AMICI PHARMA INC | — | November 22, 2019 |
| 15955-388 | 15955-388 | Alembic Labs LLC | — | June 26, 2019 |
| 15955-389 | 15955-389 | Alembic Labs LLC | — | June 26, 2019 |
| 62332-016 | 62332-016 | Alembic Pharmaceuticals Inc. | — | December 1, 2016 |
| 62332-017 | 62332-017 | Alembic Pharmaceuticals Inc. | — | December 1, 2016 |
| 46708-428 | 46708-428 | Alembic Pharmaceuticals Limited | — | December 1, 2016 |
| 46708-429 | 46708-429 | Alembic Pharmaceuticals Limited | — | December 1, 2016 |
| 60687-526 | 60687-526 | American Health Packaging | — | April 9, 2020 |
| 60687-550 | 60687-550 | American Health Packaging | — | March 20, 2020 |
| 76420-800 | 76420-800 | Asclemed USA, Inc. | — | February 23, 2019 |
| 76420-801 | 76420-801 | Asclemed USA, Inc. | — | February 23, 2019 |
| 65862-694 | 65862-694 | Aurobindo Pharma Limited | — | May 29, 2015 |
| 65862-695 | 65862-695 | Aurobindo Pharma Limited | — | May 29, 2015 |
| 50268-534 | 50268-534 | AvPAK | — | October 30, 2019 |
| 50268-535 | 50268-535 | AvPAK | — | October 30, 2019 |
| 63629-1386 | 63629-1386 | Bryant Ranch Prepack | — | September 30, 1990 |
| 71335-0858 | 71335-0858 | Bryant Ranch Prepack | — | September 30, 1990 |
| 71335-1681 | 71335-1681 | Bryant Ranch Prepack | — | December 1, 2016 |
| 71335-1703 | 71335-1703 | Bryant Ranch Prepack | — | February 23, 2019 |
| 71335-1775 | 71335-1775 | Bryant Ranch Prepack | — | February 23, 2019 |
| 71335-1838 | 71335-1838 | Bryant Ranch Prepack | — | May 29, 2015 |
| 71335-1922 | 71335-1922 | Bryant Ranch Prepack | — | May 29, 2015 |
| 71335-2681 | 71335-2681 | Bryant Ranch Prepack | — | February 23, 2019 |
| 71335-2949 | 71335-2949 | Bryant Ranch Prepack | — | January 4, 2025 |
| 72162-2468 | 72162-2468 | Bryant Ranch Prepack | — | January 4, 2025 |
| 55154-2343 | 55154-2343 | Cardinal Health 107, LLC | — | March 5, 2025 |
| 55154-8190 | 55154-8190 | Cardinal Health 107, LLC | — | February 20, 2020 |
| 62135-795 | 62135-795 | Chartwell RX, LLC | — | November 29, 2017 |
| 62135-796 | 62135-796 | Chartwell RX, LLC | — | November 29, 2017 |
| 51407-372 | 51407-372 | Golden State Medical Supply, Inc. | — | July 16, 1986 |
| 51407-376 | 51407-376 | Golden State Medical Supply, Inc. | — | July 16, 1986 |
| 23155-651 | 23155-651 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | November 29, 2017 |
| 23155-652 | 23155-652 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | November 29, 2017 |
| 0904-7126 | 0904-7126 | Major Pharmaceuticals | — | November 29, 2017 |
| 0904-7156 | 0904-7156 | Major Pharmaceuticals | — | November 29, 2017 |
| 58657-739 | 58657-739 | Method Pharmaceuticals LLC | — | January 4, 2025 |
| 58657-933 | 58657-933 | Method Pharmaceuticals LLC | — | July 1, 2025 |
| 58657-934 | 58657-934 | Method Pharmaceuticals LLC | — | July 1, 2025 |
| 58657-939 | 58657-939 | Method Pharmaceuticals LLC | — | July 1, 2025 |
| 51655-441 | 51655-441 | Northwind Health Company, LLC | — | November 30, 2022 |
| 51655-974 | 51655-974 | Northwind Health Company, LLC | — | February 28, 2023 |
| 82868-014 | 82868-014 | Northwind Health Company, LLC | — | September 28, 2023 |
| 68071-2251 | 68071-2251 | NuCare Pharmaceuticals,Inc. | — | November 29, 2017 |
| 68071-2288 | 68071-2288 | NuCare Pharmaceuticals,Inc. | — | December 1, 2016 |
| 68071-2399 | 68071-2399 | NuCare Pharmaceuticals,Inc. | — | May 29, 2015 |
| 68071-2409 | 68071-2409 | NuCare Pharmaceuticals,Inc. | — | February 23, 2019 |
| 68071-5073 | 68071-5073 | NuCare Pharmaceuticals,Inc. | — | December 1, 2016 |
| 68071-5283 | 68071-5283 | NuCare Pharmaceuticals,Inc. | — | November 29, 2017 |
| 72789-007 | 72789-007 | PD-Rx Pharmaceuticals, Inc. | — | December 1, 2016 |
| 72789-011 | 72789-011 | PD-Rx Pharmaceuticals, Inc. | — | December 1, 2016 |
| 72789-195 | 72789-195 | PD-Rx Pharmaceuticals, Inc. | — | February 23, 2019 |
| 68788-7815 | 68788-7815 | Preferred Pharmaceuticals Inc. | — | November 13, 2020 |
| 63187-035 | 63187-035 | Proficient Rx LP | — | September 30, 1990 |
| 63187-511 | 63187-511 | Proficient Rx LP | — | September 30, 1990 |
| 70518-0013 | 70518-0013 | REMEDYREPACK INC. | — | November 23, 2016 |
| 70518-1240 | 70518-1240 | REMEDYREPACK INC. | — | June 1, 2018 |
| 70518-1241 | 70518-1241 | REMEDYREPACK INC. | — | June 1, 2018 |
| 70518-2663 | 70518-2663 | REMEDYREPACK INC. | — | March 30, 2020 |
| 70518-3042 | 70518-3042 | REMEDYREPACK INC. | — | March 9, 2021 |
| 70518-3110 | 70518-3110 | REMEDYREPACK INC. | — | June 3, 2021 |
| 70518-3265 | 70518-3265 | REMEDYREPACK INC. | — | November 8, 2021 |
| 67296-0078 | 67296-0078 | Redpharm Drug, inc. | — | September 30, 1990 |
| 16571-664 | 16571-664 | Rising Pharma Holdings, Inc. | — | May 29, 2015 |
| 16571-665 | 16571-665 | Rising Pharma Holdings, Inc. | — | May 29, 2015 |
| 60760-539 | 60760-539 | ST. MARY'S MEDICAL PARK PHARMACY | — | June 17, 2022 |
| 85766-024 | 85766-024 | Sportpharm LLC | — | February 23, 2019 |
| 50111-333 | 50111-333 | Teva Pharmaceuticals USA, Inc. | — | September 30, 1990 |
| 50111-334 | 50111-334 | Teva Pharmaceuticals USA, Inc. | — | September 30, 1990 |
| 72578-007 | 72578-007 | Viona Pharmaceuticals Inc | — | February 23, 2019 |
| 72578-008 | 72578-008 | Viona Pharmaceuticals Inc | — | February 23, 2019 |
| 70771-1045 | 70771-1045 | Zydus Lifesciences Limited | — | February 23, 2019 |
| 70771-1046 | 70771-1046 | Zydus Lifesciences Limited | — | February 23, 2019 |
Sources for 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 |
| Drug Shortages | FDA | Supply availability |
Generated September 25, 2026 · 13 sections on this page.