Home NDC 21922-070 METRONIDAZOLE
Product NDC 21922-070
11-digit product format 219220070
Labeler code 21922
Product ID 21922-070_a0c70ee2-3ac6-4610-8592-642fd2d1aafc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole Topical
Dosage form GEL
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA077547
Marketing category ANDA
Marketing start 2025-01-28
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 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.
Additional Listing Data#
Finished product Yes
Brand name base METRONIDAZOLE
Listing expiration 2026-12-31 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21922-070-06 METRONIDAZOLE 45 g in 1 TUBE GEL 45 2 21922-070-06 METRONIDAZOLE 1 in 1 CARTON GEL 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-070 METRONIDAZOLE (METRONIDAZOLE TOPICAL) GEL [ENCUBE ETHICALS PRIVATE LIMITED] 1 Current NDC, 2 package rows 20250207_05707735-e676-412a-9a77-ebd003afb16c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 21922-070-06 21922007006 1 TUBE in 1 CARTON (21922-070-06) / 45 g in 1 TUBE 1 tube 2025-01-28 No No Current