Home NDC 0115-1474 Metronidazole
Product NDC 0115-1474
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 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 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.
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 A077547-001 METRONIDAZOLE 0.75% GEL / TOPICAL AB 2006-07-13 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 A077547-001 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 · 1 matching rows.
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
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