Home NDC 0713-0633 Metronidazole
Product NDC 0713-0633
11-digit product format 007130633
Labeler code 0713
Product ID 0713-0633_0b47088a-fa40-b41e-e063-6394a90acfb1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA077549
Marketing category ANDA
Marketing start 2008-03-13
Substance METRONIDAZOLE
Active strength 7.5 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 A077549-001 METRONIDAZOLE METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077549-001 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 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 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 A077549-001 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Metronidazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 7.5 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 311678 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0713-0633-37 Metronidazole 45 g in 1 TUBE CREAM 45 8 0713-0633-37 Metronidazole 1 in 1 CARTON CREAM 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Metronidazole ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] 2 Metronidazole ACTIVE MOIETY 140QMO216E METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] 2 Benzyl Alcohol INACTIVE INGREDIENT LKG8494WBH METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] 2 Glycerin INACTIVE INGREDIENT PDC6A3C0OX METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] 2 Isopropyl Palmitate INACTIVE INGREDIENT 8CRQ2TH63M METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] 2 Lactic Acid INACTIVE INGREDIENT 33X04XA5AT METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] 2 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] 2 Sorbitol INACTIVE INGREDIENT 506T60A25R METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R METRONIDAZOLE (METRONIDAZOLE) CREAM [G&W LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0633 METRONIDAZOLE CREAM [COSETTE PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20231130_de4cb39f-cc6e-98fb-05e5-103f3aca2dad.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 0713-0633-37 00713063337 1 TUBE in 1 CARTON (0713-0633-37) / 45 g in 1 TUBE 1 tube 2008-03-13 0000-00-00 No No Current