metronidazole

Generic: metronidazole

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler cadila pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metronidazole 250 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-062
Product ID 71209-062_1b7de98f-0359-4ba0-8705-85bb7c53be03
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209794
Listing Expiration 2026-12-31
Marketing Start 2017-12-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71209062
Hyphenated Format 71209-062

Supplemental Identifiers

RxCUI
311681 314106
UPC
0371209062107 0371209063029 0371209063104 0371209062022
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 ANDA209794 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 50 TABLET, FILM COATED in 1 BOTTLE (71209-062-02)
  • 500 TABLET, FILM COATED in 1 BOTTLE (71209-062-10)
source: ndc

Packages (2)

71209-062-02 50 TABLET, FILM COATED in 1 BOTTLE (71209-062-02) 71209-062-10 500 TABLET, FILM COATED in 1 BOTTLE (71209-062-10)

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": "1b7de98f-0359-4ba0-8705-85bb7c53be03", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0371209062107", "0371209063029", "0371209063104", "0371209062022"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106"], "spl_set_id": ["0c55bfc1-770a-4cce-a5dd-446000b24f16"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (71209-062-02)", "package_ndc": "71209-062-02", "marketing_start_date": "20171229"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (71209-062-10)", "package_ndc": "71209-062-10", "marketing_start_date": "20171229"}], "brand_name": "Metronidazole", "product_id": "71209-062_1b7de98f-0359-4ba0-8705-85bb7c53be03", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "71209-062", "generic_name": "Metronidazole", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "250 mg/1"}], "application_number": "ANDA209794", "marketing_category": "ANDA", "marketing_start_date": "20171229", "listing_expiration_date": "20261231"}