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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.

ApplicationSponsorOriginal approvalListings
NDA 018657BAXTER HLTHCARE1981-12-243
NDA 018900B BRAUN1983-09-291
ANDA 070027TEVA PHARMS USA1984-12-064
ANDA 070033PLIVA1984-12-066
ANDA 070772INNOGENIX1986-07-1613
NDA 020531GALDERMA LABS LP1995-09-202
NDA 020743BAUSCH1997-09-262
ANDA 076522CHARTWELL RX2004-01-291
ANDA 076408FOUGERA PHARMS2004-05-282
NDA 021806TEVA PHARMS2005-05-201
ANDA 077197FOUGERA PHARMS2006-05-241
ANDA 077547ENCUBE2006-07-131
ANDA 077819TARO2006-07-182
ANDA 077549COSETTE PHARMS NC2007-12-191
ANDA 079067ALEMBIC PHARMS LTD2009-03-1311
ANDA 079065ALEMBIC2009-06-232
ANDA 090222ALEMBIC2010-05-051
ANDA 078178COSETTE PHARMS NC2011-01-191
ANDA 203458UNICHEM2014-01-2233
ANDA 203974AUROBINDO PHARMA LTD2015-05-299
ANDA 205245SOMERSET THERAPS LLC2015-09-2312
ANDA 206560CADILA2016-11-1617
ANDA 204651TARO2017-03-142
ANDA 208681ALEMBIC2017-06-202
ANDA 209794CADILA PHARMS LTD2017-12-126
ANDA 206191INFORLIFE2019-02-254
ANDA 211786PADAGIS ISRAEL2019-07-023
ANDA 212435GLAND2020-08-032
ANDA 212646ALEMBIC2021-09-032
ANDA 213648AMVIKA2021-10-143
ANDA 215794GLENMARK PHARMS LTD2022-01-274
ANDA 216692COSETTE PHARMS NC2023-01-231
ANDA 217128ZYDUS LIFESCIENCES2023-04-213
ANDA 217665AMNEAL2023-05-241
ANDA 215610ENCUBE2023-06-161
ANDA 216323COSETTE PHARMS NC2023-07-121
NDA 216755SAPTALIS PHARMS2023-09-222
ANDA 216795ENCUBE2024-03-181
ANDA 216750SCIEGEN PHARMS2024-12-312
ANDA 220095ZYDUS LIFESCIENCES2026-02-132

Showing 40 of 47 applications.

Official labeling on DailyMed

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.