metronidazole

Generic: metronidazole

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler viona pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 250 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-007
Product ID 72578-007_855f53ac-75a4-48d0-9845-1de91708154d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206560
Listing Expiration 2026-12-31
Marketing Start 2019-02-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72578007
Hyphenated Format 72578-007

Supplemental Identifiers

RxCUI
311681 314106
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 ANDA206560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72578-007-01)
  • 500 TABLET in 1 BOTTLE (72578-007-05)
  • 250 TABLET in 1 BOTTLE (72578-007-21)
source: ndc

Packages (3)

72578-007-01 100 TABLET in 1 BOTTLE (72578-007-01) 72578-007-05 500 TABLET in 1 BOTTLE (72578-007-05) 72578-007-21 250 TABLET in 1 BOTTLE (72578-007-21)

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": "855f53ac-75a4-48d0-9845-1de91708154d", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106"], "spl_set_id": ["0f108035-d2ab-49c1-9f8d-daae11f0efe0"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72578-007-01)", "package_ndc": "72578-007-01", "marketing_start_date": "20190223"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72578-007-05)", "package_ndc": "72578-007-05", "marketing_start_date": "20190223"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (72578-007-21)", "package_ndc": "72578-007-21", "marketing_start_date": "20190223"}], "brand_name": "metronidazole", "product_id": "72578-007_855f53ac-75a4-48d0-9845-1de91708154d", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "72578-007", "generic_name": "metronidazole", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "250 mg/1"}], "application_number": "ANDA206560", "marketing_category": "ANDA", "marketing_start_date": "20190223", "listing_expiration_date": "20261231"}