Active ingredient
Metronidazole
176 finished FDA listings contain Metronidazole as their only active ingredient; 6 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- METRONIDAZOLE, METRONIDAZOLE BENZOATE
- Dosage forms
- Capsule, Cream, Gel, Injection, Solution, Lotion, Solution, Suspension, Tablet, Tablet, Film Coated, Tablet, Film Coated, Extended Release
- Routes
- Cutaneous, Intravenous, Oral, Topical, Vaginal
- Manufacturers / labelers
- 69
- Strengths listed
- 1 g/1 · 10 mg/60g · 10 mg/g · 100 mg/ml · 125 mg/1 · 250 mg/1 · 375 mg/1 · 5 mg/ml · 500 mg/1 · 500 mg/100ml · 65 mg/5g · 7.5 mg/g · 7.5 mg/ml · 750 mg/1
- Brand names in FDA listings
- Flagyl, Likmez, Metronidazole, Metronidazole Vaginal, Metronidazole Vaginal Gel, Metronidazole Vaginal Gel, 0.75%, Noritate, Nuvessa, Vagizole, Vandazole
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6922
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 018657 | BAXTER HLTHCARE | 1981-12-24 | 3 |
| NDA 018900 | B BRAUN | 1983-09-29 | 1 |
| ANDA 070027 | TEVA PHARMS USA | 1984-12-06 | 4 |
| ANDA 070033 | PLIVA | 1984-12-06 | 6 |
| ANDA 070772 | INNOGENIX | 1986-07-16 | 13 |
| NDA 020531 | GALDERMA LABS LP | 1995-09-20 | 2 |
| NDA 020743 | BAUSCH | 1997-09-26 | 2 |
| ANDA 076522 | CHARTWELL RX | 2004-01-29 | 1 |
| ANDA 076408 | FOUGERA PHARMS | 2004-05-28 | 2 |
| NDA 021806 | TEVA PHARMS | 2005-05-20 | 1 |
| ANDA 077197 | FOUGERA PHARMS | 2006-05-24 | 1 |
| ANDA 077547 | ENCUBE | 2006-07-13 | 1 |
| ANDA 077819 | TARO | 2006-07-18 | 2 |
| ANDA 077549 | COSETTE PHARMS NC | 2007-12-19 | 1 |
| ANDA 079067 | ALEMBIC PHARMS LTD | 2009-03-13 | 11 |
| ANDA 079065 | ALEMBIC | 2009-06-23 | 2 |
| ANDA 090222 | ALEMBIC | 2010-05-05 | 1 |
| ANDA 078178 | COSETTE PHARMS NC | 2011-01-19 | 1 |
| ANDA 203458 | UNICHEM | 2014-01-22 | 33 |
| ANDA 203974 | AUROBINDO PHARMA LTD | 2015-05-29 | 9 |
| ANDA 205245 | SOMERSET THERAPS LLC | 2015-09-23 | 12 |
| ANDA 206560 | CADILA | 2016-11-16 | 17 |
| ANDA 204651 | TARO | 2017-03-14 | 2 |
| ANDA 208681 | ALEMBIC | 2017-06-20 | 2 |
| ANDA 209794 | CADILA PHARMS LTD | 2017-12-12 | 6 |
| ANDA 206191 | INFORLIFE | 2019-02-25 | 4 |
| ANDA 211786 | PADAGIS ISRAEL | 2019-07-02 | 3 |
| ANDA 212435 | GLAND | 2020-08-03 | 2 |
| ANDA 212646 | ALEMBIC | 2021-09-03 | 2 |
| ANDA 213648 | AMVIKA | 2021-10-14 | 3 |
| ANDA 215794 | GLENMARK PHARMS LTD | 2022-01-27 | 4 |
| ANDA 216692 | COSETTE PHARMS NC | 2023-01-23 | 1 |
| ANDA 217128 | ZYDUS LIFESCIENCES | 2023-04-21 | 3 |
| ANDA 217665 | AMNEAL | 2023-05-24 | 1 |
| ANDA 215610 | ENCUBE | 2023-06-16 | 1 |
| ANDA 216323 | COSETTE PHARMS NC | 2023-07-12 | 1 |
| NDA 216755 | SAPTALIS PHARMS | 2023-09-22 | 2 |
| ANDA 216795 | ENCUBE | 2024-03-18 | 1 |
| ANDA 216750 | SCIEGEN PHARMS | 2024-12-31 | 2 |
| ANDA 220095 | ZYDUS LIFESCIENCES | 2026-02-13 | 2 |
Showing 40 of 47 applications.
Official labeling on DailyMed
- METRONIDAZOLE TABLET [MAJOR PHARMACEUTICALS] · version 6 · 2026-09-02
- METRONIDAZOLE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] · version 9 · 2026-08-28
- METRONIDAZOLE TABLET [TEVA PHARMACEUTICALS USA, INC.] · version 19 · 2026-08-17
- METRONIDAZOLE TABLET [REMEDYREPACK INC.] · version 13 · 2026-08-07
- METRONIDAZOLE TABLET [REMEDYREPACK INC.] · version 14 · 2026-08-06
- METRONIDAZOLE TABLET [REMEDYREPACK INC.] · version 13 · 2026-08-04
- METRONIDAZOLE TABLET [REMEDYREPACK INC.] · version 23 · 2026-07-29
- VAGIZOLE (METRONIDAZOLE) GEL [INUTRITION LLC] · version 4 · 2026-07-24
- METRONIDAZOLE TABLET, FILM COATED [REMEDYREPACK INC.] · version 13 · 2026-07-24
- METRONIDAZOLE TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 100 · 2026-07-16
- METRONIDAZOLE GEL [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 7 · 2026-07-16
- METRONIDAZOLE GEL [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 6 · 2026-07-16
Showing the 12 most recent of 150 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.