Home NDC 50090-2126 Metronidazole
Product NDC 50090-2126
11-digit product format 500902126
Labeler code 50090
Product ID 50090-2126_e39bafb7-205b-4ad7-9391-df7c04a88c12
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form GEL
Route VAGINAL
Labeler A-S Medication Solutions
Application NDA020208
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-04-01
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 N020208-001 METROGEL-VAGINAL METRONIDAZOLE 0.75% GEL / VAGINAL RLD 1992-08-17
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 N020208-001 METROGEL-VAGINAL 0.75% GEL / VAGINAL RLD 1992-08-17 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 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 50090-2126-0 Metronidazole 70 g in 1 TUBE, WITH APPLICATOR GEL 70 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-2126 METRONIDAZOLE GEL [A-S MEDICATION SOLUTIONS] 10 Current NDC, Legacy NDC, 1 package rows 20231026_8b2c294b-ed70-447c-bbc4-2a8b59f1aca4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-2126-0 50090212600 70 g in 1 TUBE, WITH APPLICATOR (50090-2126-0) 70 g 2015-10-15 0000-00-00 No No Current