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 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 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.
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 2026-08-01 22:54:32 2026-06 A076408-001 METRONIDAZOLE 0.75% CREAM / TOPICAL AB RS 2004-05-28 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A076408-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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
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