metronidazole

Generic: metronidazole

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 250 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-534
Product ID 50268-534_de5b2643-fb04-3d31-e053-2a95a90a28c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079067
Listing Expiration 2026-12-31
Marketing Start 2019-10-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268534
Hyphenated Format 50268-534

Supplemental Identifiers

RxCUI
311681 314106
UNII
140QMO216E
NUI
N0000175435 M0014907

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 ANDA079067 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-534-15) / 1 TABLET in 1 BLISTER PACK (50268-534-11)
source: ndc

Packages (1)

50268-534-15 50 BLISTER PACK in 1 BOX (50268-534-15) / 1 TABLET in 1 BLISTER PACK (50268-534-11)

Ingredients (1)

metronidazole (250 mg/1)

Linked Drug Pages (1)

Metronidazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "de5b2643-fb04-3d31-e053-2a95a90a28c4", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106"], "spl_set_id": ["9623181f-5e3b-3695-e053-2a95a90a99f6"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-534-15)  / 1 TABLET in 1 BLISTER PACK (50268-534-11)", "package_ndc": "50268-534-15", "marketing_start_date": "20191030"}], "brand_name": "Metronidazole", "product_id": "50268-534_de5b2643-fb04-3d31-e053-2a95a90a28c4", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "50268-534", "generic_name": "Metronidazole", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "250 mg/1"}], "application_number": "ANDA079067", "marketing_category": "ANDA", "marketing_start_date": "20191030", "listing_expiration_date": "20261231"}