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 500 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-005
Product ID 72789-005_4030e04e-82a0-ee5a-e063-6294a90ad816
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 72789005
Hyphenated Format 72789-005

Supplemental Identifiers

RxCUI
311681
UPC
0372789005140
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
  • 500 mg/1
source: ndc
Packaging
  • 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-005-14)
source: ndc

Packages (1)

72789-005-14 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-005-14)

Ingredients (1)

metronidazole (500 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": "4030e04e-82a0-ee5a-e063-6294a90ad816", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0372789005140"], "unii": ["140QMO216E"], "rxcui": ["311681"], "spl_set_id": ["4cdd7ac5-a52c-4766-afeb-1b5e567a328c"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-005-14)", "package_ndc": "72789-005-14", "marketing_start_date": "20190830"}], "brand_name": "Metronidazole", "product_id": "72789-005_4030e04e-82a0-ee5a-e063-6294a90ad816", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "72789-005", "generic_name": "Metronidazole", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/1"}], "application_number": "ANDA203458", "marketing_category": "ANDA", "marketing_start_date": "20140601", "listing_expiration_date": "20261231"}