metronidazole

Generic: metronidazole

Labeler: taro pharmaceuticals u.s.a., inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler taro pharmaceuticals u.s.a., inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

metronidazole 10 mg/g

Manufacturer
Taro Pharmaceuticals U.S.A., Inc.

Identifiers & Regulatory

Product NDC 51672-4215
Product ID 51672-4215_a0569c03-e6a4-4bc0-8c9d-f2f84f24cf2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204651
Listing Expiration 2026-12-31
Marketing Start 2019-04-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516724215
Hyphenated Format 51672-4215

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 ANDA204651 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-4215-3) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-4215-6) / 45 g in 1 TUBE
  • 1 BOTTLE, PUMP in 1 CARTON (51672-4215-9) / 55 g in 1 BOTTLE, PUMP
source: ndc

Packages (3)

51672-4215-3 1 TUBE in 1 CARTON (51672-4215-3) / 60 g in 1 TUBE 51672-4215-6 1 TUBE in 1 CARTON (51672-4215-6) / 45 g in 1 TUBE 51672-4215-9 1 BOTTLE, PUMP in 1 CARTON (51672-4215-9) / 55 g in 1 BOTTLE, PUMP

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": "a0569c03-e6a4-4bc0-8c9d-f2f84f24cf2a", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["577237"], "spl_set_id": ["5842a554-58d1-4ee4-99aa-1e6029a69be2"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Taro Pharmaceuticals U.S.A., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-4215-3)  / 60 g in 1 TUBE", "package_ndc": "51672-4215-3", "marketing_start_date": "20190409"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-4215-6)  / 45 g in 1 TUBE", "package_ndc": "51672-4215-6", "marketing_start_date": "20190409"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (51672-4215-9)  / 55 g in 1 BOTTLE, PUMP", "package_ndc": "51672-4215-9", "marketing_start_date": "20190409"}], "brand_name": "Metronidazole", "product_id": "51672-4215_a0569c03-e6a4-4bc0-8c9d-f2f84f24cf2a", "dosage_form": "GEL", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "51672-4215", "generic_name": "Metronidazole", "labeler_name": "Taro Pharmaceuticals U.S.A., Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "10 mg/g"}], "application_number": "ANDA204651", "marketing_category": "ANDA", "marketing_start_date": "20190409", "listing_expiration_date": "20261231"}