metronidazole

Generic: metronidazole

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler cosette pharmaceuticals, inc.
Dosage Form GEL
Routes
VAGINAL
Active Ingredients

metronidazole 7.5 mg/g

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0575
Product ID 0713-0575_00beeda9-9cf9-730b-e063-6294a90a8ad0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216323
Listing Expiration 2026-12-31
Marketing Start 2023-07-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130575
Hyphenated Format 0713-0575

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 (source: ndc)
Generic Name metronidazole (source: ndc)
Application Number ANDA216323 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/g
source: ndc
Packaging
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (0713-0575-71) / 70 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (1)

0713-0575-71 1 TUBE, WITH APPLICATOR in 1 CARTON (0713-0575-71) / 70 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

metronidazole (7.5 mg/g)

Linked Drug Pages (1)

Metronidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "00beeda9-9cf9-730b-e063-6294a90a8ad0", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["142046"], "spl_set_id": ["d76810d5-11b4-4b5e-b850-230f59376c34"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (0713-0575-71)  / 70 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "0713-0575-71", "marketing_start_date": "20230712"}], "brand_name": "Metronidazole", "product_id": "0713-0575_00beeda9-9cf9-730b-e063-6294a90a8ad0", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "0713-0575", "generic_name": "metronidazole", "labeler_name": "Cosette Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "7.5 mg/g"}], "application_number": "ANDA216323", "marketing_category": "ANDA", "marketing_start_date": "20230712", "listing_expiration_date": "20261231"}