Home NDC 43538-181 Rosadan
Product NDC 43538-181
11-digit product format 435380181
Labeler code 43538
Product ID 43538-181_8238843a-fb3b-4234-9caf-9315624f5a81
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form CREAM
Route TOPICAL
Labeler Medimetriks Pharmaceuticals, Inc.
Application ANDA077549
Marketing category ANDA
Marketing start 2011-08-30
Marketing end 0000-00-00
Substance METRONIDAZOLE
Active strength 8 mg/g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 43538-181-45 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 43538-181-45 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 43538-181-45 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 43538-181-45 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 43538-181-45 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 43538-181-45 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 43538-181-45 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 43538-181-45 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 43538-181-45 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 43538-181-45 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 43538-181-45 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 43538-181-45 557ba5c1ecfa…9c80585c8c6e…
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.
Product history page 1 of 2 · 41 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 2026-02-19 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077549-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2007-12-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded metronidazole ACTIVE INGREDIENT 140QMO216E ROSADAN (METRONIDAZOLE) CREAM [MEDIMETRIKS PHARMACEUTICALS, INC.] 1 metronidazole ACTIVE MOIETY 140QMO216E ROSADAN (METRONIDAZOLE) CREAM [MEDIMETRIKS PHARMACEUTICALS, INC.] 1 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH ROSADAN (METRONIDAZOLE) CREAM [MEDIMETRIKS PHARMACEUTICALS, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX ROSADAN (METRONIDAZOLE) CREAM [MEDIMETRIKS PHARMACEUTICALS, INC.] 1 isopropyl palmitate INACTIVE INGREDIENT 8CRQ2TH63M ROSADAN (METRONIDAZOLE) CREAM [MEDIMETRIKS PHARMACEUTICALS, INC.] 1 lactic acid INACTIVE INGREDIENT 33X04XA5AT ROSADAN (METRONIDAZOLE) CREAM [MEDIMETRIKS PHARMACEUTICALS, INC.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I ROSADAN (METRONIDAZOLE) CREAM [MEDIMETRIKS PHARMACEUTICALS, INC.] 1 sorbitol INACTIVE INGREDIENT 506T60A25R ROSADAN (METRONIDAZOLE) CREAM [MEDIMETRIKS PHARMACEUTICALS, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R ROSADAN (METRONIDAZOLE) CREAM [MEDIMETRIKS PHARMACEUTICALS, INC.] 1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43538-181-45 43538018145 1 TUBE in 1 KIT (43538-181-45) > 45 g in 1 TUBE 1 tube 2011-08-30 0000-00-00 No No Current