metronidazole

Generic: metronidazole

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metronidazole 250 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-719
Product ID 43063-719_414af257-be78-1935-e063-6394a90a7b1a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203458
Listing Expiration 2026-12-31
Marketing Start 2014-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063719
Hyphenated Format 43063-719

Supplemental Identifiers

RxCUI
314106
UPC
0343063719213
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
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-06)
  • 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-21)
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-28)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-30)
  • 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-56)
source: ndc

Packages (5)

43063-719-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-06) 43063-719-21 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-21) 43063-719-28 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-28) 43063-719-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-30) 43063-719-56 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-56)

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": "414af257-be78-1935-e063-6394a90a7b1a", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0343063719213"], "unii": ["140QMO216E"], "rxcui": ["314106"], "spl_set_id": ["353b7f5b-4bbc-4ec9-84ba-d82656ea1811"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-06)", "package_ndc": "43063-719-06", "marketing_start_date": "20161102"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-21)", "package_ndc": "43063-719-21", "marketing_start_date": "20170501"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-28)", "package_ndc": "43063-719-28", "marketing_start_date": "20170503"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-30)", "package_ndc": "43063-719-30", "marketing_start_date": "20161024"}, {"sample": false, "description": "56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-719-56)", "package_ndc": "43063-719-56", "marketing_start_date": "20180405"}], "brand_name": "Metronidazole", "product_id": "43063-719_414af257-be78-1935-e063-6394a90a7b1a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "43063-719", "generic_name": "Metronidazole", "labeler_name": "PD-Rx Pharmaceuticals, 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": "20140601", "listing_expiration_date": "20261231"}