Home NDC 51672-4116 Metronidazole
Product NDC 51672-4116
11-digit product format 516724116
Labeler code 51672
Product ID 51672-4116_d5b90aeb-7cd5-48b8-97a5-8d6f3307e2a3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form GEL
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA077819
Marketing category ANDA
Marketing start 2006-07-18
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 A077819-001 METRONIDAZOLE METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077819-001 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 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077819-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-18 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 2027-12-31 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 311679 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded metronidazole ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 metronidazole ACTIVE MOIETY 140QMO216E METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 carbomer homopolymer type c INACTIVE INGREDIENT 4Q93RCW27E METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 edetate disodium INACTIVE INGREDIENT 7FLD91C86K METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 methylparaben INACTIVE INGREDIENT A2I8C7HI9T METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 3 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.] 1 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.] 1 CARBOMER HOMOPOLYMER TYPE C INACTIVE INGREDIENT 4Q93RCW27E METRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K METRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T METRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH METRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R METRONIDAZOLE GEL [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4116 METRONIDAZOLE GEL [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 5 package rows 20170330_4a233572-2471-4e99-a45e-2de978abcf16.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 · 2 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 51672-4116-2 51672411602 1 TUBE in 1 CARTON (51672-4116-2) / 30 g in 1 TUBE 1 tube 2006-07-18 0000-00-00 No No Current 51672-4116-5 51672411605 5 g in 1 TUBE (51672-4116-5) 5 g 2006-07-18 0000-00-00 No No Current 51672-4116-6 51672411606 1 TUBE in 1 CARTON (51672-4116-6) / 45 g in 1 TUBE 1 tube 2006-07-18 0000-00-00 No No Current