Home NDC 0115-1474-46 Metronidazole
Product NDC 0115-1474
Requested package NDC 0115-1474-46
11-digit product format 001151474
Labeler code 0115
Product ID 0115-1474_943c4651-3d73-4af2-b4b7-b7d9027f73f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form GEL
Route TOPICAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA077547
Marketing category ANDA
Marketing start 2006-07-13
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A077547-001 METRONIDAZOLE METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077547-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 CARBOMER HOMOPOLYMER TYPE C INACTIVE INGREDIENT 4Q93RCW27E METRONIDAZOLE GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K METRONIDAZOLE GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T METRONIDAZOLE GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METRONIDAZOLE GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH METRONIDAZOLE GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METRONIDAZOLE GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R METRONIDAZOLE GEL [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES 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 0115-1474-46 00115147446 1 TUBE in 1 CARTON (0115-1474-46) > 45 g in 1 TUBE 1 tube 2006-07-13 0000-00-00 No No Current