Home NDC 51672-4215 Metronidazole
Product NDC 51672-4215
11-digit product format 516724215
Labeler code 51672
Product ID 51672-4215_a0569c03-e6a4-4bc0-8c9d-f2f84f24cf2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form GEL
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA204651
Marketing category ANDA
Marketing start 2019-04-09
Substance METRONIDAZOLE
Active strength 10 mg/g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204651-001 METRONIDAZOLE METRONIDAZOLE 1% GEL / TOPICAL AB 2017-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204651-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A204651-001 METRONIDAZOLE 1% GEL / TOPICAL AB 2017-03-14 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A204651-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Metronidazole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 140QMO216E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 577237 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4215 METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 6 package rows 20230125_5842a554-58d1-4ee4-99aa-1e6029a69be2.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-4215-3 51672421503 1 TUBE in 1 CARTON (51672-4215-3) / 60 g in 1 TUBE 1 tube 2019-04-09 0000-00-00 No No Current 51672-4215-6 51672421506 1 TUBE in 1 CARTON (51672-4215-6) / 45 g in 1 TUBE 1 tube 2019-04-09 0000-00-00 No No Current 51672-4215-9 51672421509 1 BOTTLE, PUMP in 1 CARTON (51672-4215-9) / 55 g in 1 BOTTLE, PUMP 2019-04-09 0000-00-00 No No Current