Home NDC 21922-039 Metronidazole Vaginal Gel, 0.75%
Product NDC 21922-039
11-digit product format 219220039
Labeler code 21922
Product ID 21922-039_15d347d5-e345-4750-9f5e-6c2b4f9c583a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form GEL
Route VAGINAL
Labeler Encube Ethicals, Inc.
Application ANDA215610
Marketing category ANDA
Marketing start 2023-06-17
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 A215610-001 METRONIDAZOLE METRONIDAZOLE 0.75% GEL / VAGINAL AB RS 2023-06-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215610-001 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 A215610-001 METRONIDAZOLE 0.75% GEL / VAGINAL AB RS 2023-06-16 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 A215610-001 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 Vaginal Gel, 0.75%
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 142046 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 21922-039-23 Metronidazole Vaginal Gel, 0.75% 1 in 1 CARTON GEL 1 3 21922-039-23 Metronidazole Vaginal Gel, 0.75% 70 g in 1 TUBE, WITH APPLICATOR GEL 70 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-039 METRONIDAZOLE VAGINAL GEL, 0.75% (METRONIDAZOLE) GEL [ENCUBE ETHICALS PRIVATE LIMITED] 2 Current NDC, 2 package rows 20250101_63ed1e7e-d264-4e35-af83-ec37fa5b06d1.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 21922-039-23 21922003923 1 TUBE, WITH APPLICATOR in 1 CARTON (21922-039-23) / 70 g in 1 TUBE, WITH APPLICATOR 2023-06-17 No No Current