metronidazole

Generic: metronidazole

Labeler: mayne pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler mayne pharma inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

metronidazole 10 mg/g

Manufacturer
Mayne Pharma Inc.

Identifiers & Regulatory

Product NDC 68308-663
Product ID 68308-663_a5dc0ad6-1b71-45f9-b00b-cac2f5e2a26b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021789
Listing Expiration 2026-12-31
Marketing Start 2023-11-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68308663
Hyphenated Format 68308-663

Supplemental Identifiers

RxCUI
577237
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 NDA021789 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (68308-663-55) / 55 g in 1 BOTTLE, PUMP
  • 1 TUBE in 1 CARTON (68308-663-60) / 60 g in 1 TUBE
source: ndc

Packages (2)

68308-663-55 1 BOTTLE, PUMP in 1 CARTON (68308-663-55) / 55 g in 1 BOTTLE, PUMP 68308-663-60 1 TUBE in 1 CARTON (68308-663-60) / 60 g in 1 TUBE

Ingredients (1)

metronidazole (10 mg/g)

Linked Drug Pages (1)

Metronidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "a5dc0ad6-1b71-45f9-b00b-cac2f5e2a26b", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["577237"], "spl_set_id": ["3c25a3f9-52fc-448e-a044-f63b9dadcd4a"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Mayne Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (68308-663-55)  / 55 g in 1 BOTTLE, PUMP", "package_ndc": "68308-663-55", "marketing_start_date": "20231110"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68308-663-60)  / 60 g in 1 TUBE", "package_ndc": "68308-663-60", "marketing_start_date": "20250519"}], "brand_name": "Metronidazole", "product_id": "68308-663_a5dc0ad6-1b71-45f9-b00b-cac2f5e2a26b", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "68308-663", "generic_name": "metronidazole", "labeler_name": "Mayne Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "10 mg/g"}], "application_number": "NDA021789", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20231110", "listing_expiration_date": "20261231"}