Home NDC 21922-046 Metronidazole Vaginal Gel
Product NDC 21922-046
11-digit product format 219220046
Labeler code 21922
Product ID 21922-046_fcf2dac3-2804-44d2-92ce-03c83220388c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole vaginal gel, 1.3 %
Dosage form GEL
Route VAGINAL
Labeler Encube Ethicals, Inc.
Application ANDA216795
Marketing category ANDA
Marketing start 2024-03-19
Substance METRONIDAZOLE
Active strength 65 mg/5g
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 A216795-001 METRONIDAZOLE METRONIDAZOLE 1.3% GEL / VAGINAL 2024-03-18
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 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL 2024-03-18 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 Vaginal Gel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 65 mg/5g
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 1608253 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 21922-046-41 Metronidazole Vaginal Gel 5 g in 1 APPLICATOR GEL 5 2 21922-046-41 Metronidazole Vaginal Gel 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 21922-046 METRONIDAZOLE VAGINAL GEL (METRONIDAZOLE VAGINAL GEL, 1.3 %) GEL [ENCUBE ETHICALS PRIVATE LIMITED] 1 Current NDC, 2 package rows 20240321_585d2553-e19f-4227-82db-e4c2034863bf.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 21922-046-41 21922004641 1 APPLICATOR in 1 CARTON (21922-046-41) / 5 g in 1 APPLICATOR 1 applicator 2024-03-19 No No Current