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 42 .
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 2026-08-18 06:07:40 2026-07 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL 2024-03-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL 2024-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL 2024-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL 2024-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL 2024-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL 2024-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL AB 2024-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL AB 2024-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL AB 2024-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL AB 2024-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL AB 2024-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL AB 2024-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL AB 2024-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL AB 2024-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL AB 2024-03-18 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216795-001 METRONIDAZOLE 1.3% GEL / VAGINAL 2024-03-18 a50c72e98297…
Observed Orange Book normalized TE history# 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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