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Prescription medicine · generic available

Metronidazole

Brand names: Metronidazole Vaginal, Metronidazole Vaginal Gel, Likmez, Vagizole, Noritate, Flagyl, Metronidazole Vaginal Gel, 0.75%, Nuvessa, Vandazole

Drug class: Nitroimidazole Antimicrobial

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

YesBoxed warning
Current shortageFDA shortage list
2Recalls (FDA reports)
65Companies
1981First FDA approval on file

Quick answers

What is Metronidazole used for?
The FDA-approved label (Likmez, Saptalis Pharmaceuticals, LLC, April 18, 2025) says: “LIKMEZ is a nitroimidazole antimicrobial indicated for Trichomoniasis in adults Amebiasis in adults and pediatric patients Anaerobic Bacterial Infections in adults To reduce the development of drug-resistant bacteria and maintain the effectiveness of LIKMEZ and other antibacterial drugs, LIKMEZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Metronidazole have a boxed warning?
Yes. The FDA label for Likmez has a boxed warning (“WARNING: POTENTIAL FOR CARCINOGENICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Metronidazole?
The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 21, 2026). Ask your pharmacist about alternatives.
Has Metronidazole been recalled?
FDA enforcement reports list 2 recalls of products of this medicine; the newest started January 21, 2016 (Class I). A recall usually concerns specific lots, not every product.
Who makes Metronidazole?
65 companies list prescription products of Metronidazole in the FDA NDC Directory, including Bryant Ranch Prepack, Remedyrepack Inc. and A-S Medication Solutions.

What Metronidazole is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

LIKMEZ is a nitroimidazole antimicrobial indicated for Trichomoniasis in adults Amebiasis in adults and pediatric patients Anaerobic Bacterial Infections in adults To reduce the development of drug-resistant bacteria and maintain the effectiveness of LIKMEZ and other antibacterial drugs, LIKMEZ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. …

— FDA label: Likmez, Saptalis Pharmaceuticals, LLC, effective April 18, 2025. Read the full label on DailyMed →

The FDA has 146 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

PneumoniaSepsis

Related medical specialties

Infectious Disease

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: POTENTIAL FOR CARCINOGENICITY. Read it on the full label →

101 of 146 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet · Tablet, film coated · Gel · Cream · Injection, solution · Capsule · Lotion · Suspension · Tablet, film coated, extended release · Solution
RouteOral · Topical · Vaginal · Intravenous
Prescription products177 in the FDA NDC Directory
Brand namesMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez, Vagizole, Noritate, Flagyl, Metronidazole Vaginal Gel, 0.75%, Nuvessa, Vandazole

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Metronidazole, by strength and form
Strength and formGeneric or brandPharmacies pay
metronidazole 0.75%
cream		 Generic $0.2594 per gram
metronidazole 0.75%
gel		 Generic $0.1463–$0.1992 per gram
11 packages, lowest to highest
metronidazole 0.75%
gel		 Brand: Vandazole $0.3462 per gram
metronidazole 0.75%
lotion		 Generic $1.82 per mL
metronidazole 1%
gel		 Generic $0.5597–$0.6328 per gram
8 packages, lowest to highest
metronidazole 100 mg/mL
suspension		 Brand: Likmez $2.60–$2.60 per mL
2 packages, lowest to highest
metronidazole 250 mg
tablet		 Generic $0.1079 per tablet
metronidazole 250 mg
tablet, film coated		 Generic $0.1079 per tablet
metronidazole 375 mg
capsule		 Generic $9.13 per capsule
metronidazole 500 mg
tablet		 Generic $0.1045 per tablet
metronidazole 500 mg
tablet, film coated		 Generic $0.1045 per tablet
metronidazole 65 mg/5 g
gel		 Brand: Nuvessa $42.98 per gram
metronidazole 7.5 mg/mL
lotion		 Generic $1.82 per mL

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA018657
FLAGYL I.V. RTU IN PLASTIC CONTAINER		 Baxter HlthcareDecember 24, 1981 37, latest June 24, 2025
2025: Labeling · 2025: Labeling · 2024: Labeling
NDA018900
METRO I.V. IN PLASTIC CONTAINER		 B BraunSeptember 29, 1983 25, latest April 23, 2026
2026: Labeling · 2025: Labeling · 2024: Labeling
NDA020208
METROGEL-VAGINAL		 BauschAugust 17, 1992 8, latest April 17, 2002
2002: Manufacturing (CMC) · 1997: Labeling · 1997: Efficacy
NDA020334
FLAGYL		 PfizerMay 3, 1995 10, latest July 8, 2024
2024: Labeling · 2023: Labeling · 2021: Labeling
NDA020531
METROCREAM		 Galderma Labs LPSeptember 20, 1995 1, latest August 30, 2002
2002: Manufacturing (CMC)
NDA020743
NORITATE		 BauschSeptember 26, 1997 3, latest December 5, 2014
2014: Manufacturing (CMC) · 2004: Manufacturing (CMC) · 2003: Labeling
NDA020901
METROLOTION		 Galderma Labs LPNovember 24, 1998 3, latest January 7, 2015
2015: Labeling · 2004: Labeling · 2002: Manufacturing (CMC)
NDA021789
METROGEL		 Galderma Labs LPJune 30, 2005 9, latest November 22, 2023
2023: Labeling · 2022: Labeling · 2022: Labeling
NDA021806
VANDAZOLE		 Teva PharmsMay 20, 2005 4, latest February 11, 2021
2021: Labeling · 2014: Manufacturing (CMC) · 2011: Labeling
NDA205223
NUVESSA		 Alembic TherapMarch 24, 2014 4, latest February 25, 2022
2022: Labeling · 2021: Labeling · 2018: Efficacy
NDA216755
LIKMEZ		 Saptalis PharmsSeptember 22, 2023 3, latest February 28, 2025
2025: Labeling · 2024: Labeling · 2024: Labeling

Generic approvals (37)

Shortage status

Current shortage · updated October 21, 2026 · first posted January 13, 2022

ProductMetronidazole In Plastic Container, Injection, 500 mg/100 mL (NDC 47335-993-01)
AvailabilityUnavailable
Reason givenDiscontinuation of the manufacture of the drug
CompanyGland Pharma Limited

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. January 21, 2016 · Class I · Terminated · D-0863-2016

    Presence of Particulate Matter: identified as a cloth fiber.

    Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48. — Baxter Healthcare Corp.

  2. May 21, 2013 · Class II · Terminated · D-629-2013

    Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.

    Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48 — Baxter Healthcare Corp.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)142046, 199055, 213120, 242736, 311678, 311679, 311680, 311681, 311683, 314106 … (+9)
SPL set ID of the quoted labele20c14eb-5361-4a93-ab46-a7bd9aeb9b98
FDA labels (SPL)146
FDA applicationsNDA018657, NDA018900, NDA020208, NDA020334, NDA020531, NDA020743, NDA020901, NDA021789, NDA021806, NDA205223, NDA216755, 37 ANDA
Active ingredients (FDA)METRONIDAZOLE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Likmez, Saptalis Pharmaceuticals, LLC, effective April 18, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers