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 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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