metronidazole vaginal

Generic: metronidazole

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole vaginal
Generic Name metronidazole
Labeler padagis israel pharmaceuticals ltd
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-139
Product ID 45802-139_ac51fedf-e650-40c6-a92f-d33d6f32e54b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211786
Listing Expiration 2026-12-31
Marketing Start 2019-07-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802139
Hyphenated Format 45802-139

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 ANDA211786 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-139-70) / 70 g in 1 TUBE
source: ndc

Packages (1)

Ingredients (1)

metronidazole (7.5 mg/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["VAGINAL"], "spl_id": "ac51fedf-e650-40c6-a92f-d33d6f32e54b", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["142046"], "spl_set_id": ["eb240e7b-cec8-497b-8a49-7ed768e2b431"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-139-70)  / 70 g in 1 TUBE", "package_ndc": "45802-139-70", "marketing_start_date": "20190708"}], "brand_name": "metronidazole vaginal", "product_id": "45802-139_ac51fedf-e650-40c6-a92f-d33d6f32e54b", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "45802-139", "generic_name": "metronidazole", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "metronidazole vaginal", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/g"}], "application_number": "ANDA211786", "marketing_category": "ANDA", "marketing_start_date": "20190708", "listing_expiration_date": "20261231"}