metronidazole vaginal

Generic: metronidazole

Labeler: saptalis pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole vaginal
Generic Name metronidazole
Labeler saptalis pharmaceuticals llc
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
Saptalis Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 71656-067
Product ID 71656-067_2bb2bd7b-190e-1821-e063-6294a90a5c0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216750
Listing Expiration 2026-12-31
Marketing Start 2025-03-03

Pharmacologic Class

Established (EPC)
nitroimidazole antimicrobial [epc]
Chemical Structure
nitroimidazoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71656067
Hyphenated Format 71656-067

Supplemental Identifiers

RxCUI
142046
UNII
140QMO216E
NUI
N0000175435 M0014907

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name metronidazole vaginal (source: ndc)
Generic Name metronidazole (source: ndc)
Application Number ANDA216750 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (71656-067-70) / 70 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

71656-067-70 1 TUBE, WITH APPLICATOR in 1 CARTON (71656-067-70) / 70 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

metronidazole (7.5 mg/g)

Linked Drug Pages (1)

metronidazole vaginal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "2bb2bd7b-190e-1821-e063-6294a90a5c0e", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["142046"], "spl_set_id": ["08abacec-3b6a-43e7-bfaa-2041d87a26c7"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Saptalis Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (71656-067-70)  / 70 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "71656-067-70", "marketing_start_date": "20250303"}], "brand_name": "metronidazole vaginal", "product_id": "71656-067_2bb2bd7b-190e-1821-e063-6294a90a5c0e", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "71656-067", "generic_name": "metronidazole", "labeler_name": "Saptalis Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "metronidazole vaginal", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/g"}], "application_number": "ANDA216750", "marketing_category": "ANDA", "marketing_start_date": "20250303", "listing_expiration_date": "20261231"}