metronidazole

Generic: metronidazole

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

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler pharmpak, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metronidazole 250 mg/1

Manufacturer
PharmPak, Inc.

Identifiers & Regulatory

Product NDC 54348-745
Product ID 54348-745_eaa5779b-424d-01ba-e053-2a95a90ae500
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203458
Listing Expiration 2026-12-31
Marketing Start 2019-07-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54348745
Hyphenated Format 54348-745

Supplemental Identifiers

RxCUI
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 ANDA203458 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-745-08) / 8 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

54348-745-08 1 BOTTLE in 1 BOX (54348-745-08) / 8 TABLET, FILM COATED in 1 BOTTLE

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": "eaa5779b-424d-01ba-e053-2a95a90ae500", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["314106"], "spl_set_id": ["6a77b5b6-3199-4526-bd68-2e511353d7c6"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["PharmPak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-745-08)  / 8 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-745-08", "marketing_start_date": "20190712"}], "brand_name": "Metronidazole", "product_id": "54348-745_eaa5779b-424d-01ba-e053-2a95a90ae500", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "54348-745", "generic_name": "METRONIDAZOLE", "labeler_name": "PharmPak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "250 mg/1"}], "application_number": "ANDA203458", "marketing_category": "ANDA", "marketing_start_date": "20190712", "listing_expiration_date": "20261231"}