metronidazole

Generic: metronidazole

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 500 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 50111-334
Product ID 50111-334_c6f82723-a668-4dc1-96ea-816620a5b964
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070033
Listing Expiration 2026-12-31
Marketing Start 1990-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50111334
Hyphenated Format 50111-334

Supplemental Identifiers

RxCUI
311681 314106
UPC
0350111333017 0350111334014
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 ANDA070033 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50111-334-01)
  • 500 TABLET in 1 BOTTLE (50111-334-02)
source: ndc

Packages (2)

50111-334-01 100 TABLET in 1 BOTTLE (50111-334-01) 50111-334-02 500 TABLET in 1 BOTTLE (50111-334-02)

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": "c6f82723-a668-4dc1-96ea-816620a5b964", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0350111333017", "0350111334014"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106"], "spl_set_id": ["291a45f6-ed27-4dcc-8364-358d08623797"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50111-334-01)", "package_ndc": "50111-334-01", "marketing_start_date": "19900930"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (50111-334-02)", "package_ndc": "50111-334-02", "marketing_start_date": "19900930"}], "brand_name": "Metronidazole", "product_id": "50111-334_c6f82723-a668-4dc1-96ea-816620a5b964", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "50111-334", "generic_name": "Metronidazole", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/1"}], "application_number": "ANDA070033", "marketing_category": "ANDA", "marketing_start_date": "19900930", "listing_expiration_date": "20261231"}