Home NDC 71656-067 metronidazole vaginal
Product NDC 71656-067
11-digit product format 716560067
Labeler code 71656
Product ID 71656-067_2bb2bd7b-190e-1821-e063-6294a90a5c0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name metronidazole
Dosage form GEL
Route VAGINAL
Labeler Saptalis Pharmaceuticals LLC
Application ANDA216750
Marketing category ANDA
Marketing start 2025-03-03
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 43 .
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 A216750-001 METRONIDAZOLE METRONIDAZOLE 0.75% GEL / VAGINAL AB 2024-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216750-001 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 2026-09-14 22:38:34 2026-08 A216750-001 METRONIDAZOLE 0.75% GEL / VAGINAL AB 2024-12-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216750-001 METRONIDAZOLE 0.75% GEL / VAGINAL AB 2024-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216750-001 METRONIDAZOLE 0.75% GEL / VAGINAL AB 2024-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216750-001 METRONIDAZOLE 0.75% GEL / VAGINAL AB 2024-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216750-001 METRONIDAZOLE 0.75% GEL / VAGINAL AB 2024-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216750-001 METRONIDAZOLE 0.75% GEL / VAGINAL AB 2024-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216750-001 METRONIDAZOLE 0.75% GEL / VAGINAL AB 2024-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216750-001 METRONIDAZOLE 0.75% GEL / VAGINAL AB 2024-12-31 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216750-001 METRONIDAZOLE 0.75% GEL / VAGINAL AB 2024-12-31 a50c72e98297…
Observed Orange Book normalized TE history# 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
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 71656-067-70 metronidazole vaginal 70 g in 1 TUBE, WITH APPLICATOR GEL 70 1 71656-067-70 metronidazole vaginal 1 in 1 CARTON GEL 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71656-067 METRONIDAZOLE VAGINAL (METRONIDAZOLE) GEL [SAPTALIS PHARMACEUTICALS LLC] 1 Current NDC, 2 package rows 20250304_08abacec-3b6a-43e7-bfaa-2041d87a26c7.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71656-067-70 71656006770 1 TUBE, WITH APPLICATOR in 1 CARTON (71656-067-70) / 70 g in 1 TUBE, WITH APPLICATOR 2025-03-03 No No Current