Home NDC 59651-703 Metronidazole Vaginal Gel
Product NDC 59651-703
11-digit product format 596510703
Labeler code 59651
Product ID 59651-703_2ced2460-a003-4314-897b-f4ae0ff72edf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Metronidazole
Dosage form GEL
Route VAGINAL
Labeler Aurobindo Pharma Limited
Application ANDA218485
Marketing category ANDA
Marketing start 2026-09-25
Substance METRONIDAZOLE
Active strength 7.5 mg/g
Pharmacologic classes Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A218485-001 METRONIDAZOLE METRONIDAZOLE 0.75% GEL / VAGINAL AB 2026-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218485-001 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 2026-10-15 13:18:30 2026-09 A218485-001 METRONIDAZOLE 0.75% GEL / VAGINAL AB 2026-09-25 c2088c7a36db…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A218485-001 AB 1 c2088c7a36db…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Metronidazole Vaginal Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METRONIDAZOLE 7.5 mg/g
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-703-70 59651070370 1 TUBE, WITH APPLICATOR in 1 CARTON (59651-703-70) / 70 g in 1 TUBE, WITH APPLICATOR 2026-09-25 No No Current