Home NDC 0168-0323 Metronidazole
Product NDC 0168-0323
11-digit product format 001680323
Labeler code 0168
Product ID 0168-0323_111e50c5-83e4-4817-8c3f-ed7416de2dd3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form CREAM
Route TOPICAL
Labeler Fougera Pharmaceuticals, LLC
Application ANDA076408
Marketing category ANDA
Marketing start 2004-05-28
Substance METRONIDAZOLE
Active strength 7.5 mg/g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 6 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 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 0168-0323-46 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 0168-0323-46 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 0168-0323-46 8dfbde2a14a4…c9ff85d89658…
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 A076408-001 METRONIDAZOLE METRONIDAZOLE 0.75% CREAM / TOPICAL AB RS 2004-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076408-001 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 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB RS 2004-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB RS 2004-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB RS 2004-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB RS 2004-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB 2004-05-28 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 311678 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0168-0323-46 Metronidazole 45 g in 1 TUBE CREAM 45 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded metronidazole ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 metronidazole ACTIVE MOIETY 140QMO216E METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 glycerin INACTIVE INGREDIENT PDC6A3C0OX METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 isopropyl palmitate INACTIVE INGREDIENT 8CRQ2TH63M METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 lactic acid INACTIVE INGREDIENT 33X04XA5AT METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 sorbitol INACTIVE INGREDIENT 506T60A25R METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 water INACTIVE INGREDIENT 059QF0KO0R METRONIDAZOLE CREAM [E.FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 METRONIDAZOLE ACTIVE INGREDIENT 140QMO216E METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 METRONIDAZOLE ACTIVE MOIETY 140QMO216E METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 ISOPROPYL PALMITATE INACTIVE INGREDIENT 8CRQ2TH63M METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 LACTIC ACID INACTIVE INGREDIENT 33X04XA5AT METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R METRONIDAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0323 METRONIDAZOLE CREAM [FOUGERA PHARMACEUTICALS INC.] 9 Current NDC, Legacy NDC, 1 package rows 20220701_43ed872b-63ac-4a22-9c9e-cc0e05bcc41e.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 0168-0323-46 00168032346 45 g in 1 TUBE (0168-0323-46) 45 g 2004-05-28 0000-00-00 No No Current