metronidazole

Generic: metronidazole

Labeler: amici pharma inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler amici pharma inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 500 mg/1

Manufacturer
AMICI PHARMA INC

Identifiers & Regulatory

Product NDC 69292-208
Product ID 69292-208_7287076f-6345-40c4-8ced-5b3cae45b7a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070772
Listing Expiration 2026-12-31
Marketing Start 2019-11-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69292208
Hyphenated Format 69292-208

Supplemental Identifiers

RxCUI
311681
UPC
0369292208014 0369292208502
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 ANDA070772 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69292-208-01)
  • 500 TABLET in 1 BOTTLE (69292-208-50)
source: ndc

Packages (2)

69292-208-01 100 TABLET in 1 BOTTLE (69292-208-01) 69292-208-50 500 TABLET in 1 BOTTLE (69292-208-50)

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": "7287076f-6345-40c4-8ced-5b3cae45b7a4", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0369292208014", "0369292208502"], "unii": ["140QMO216E"], "rxcui": ["311681"], "spl_set_id": ["9f1fec88-097f-42b9-a36f-214648d7eebb"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["AMICI PHARMA INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69292-208-01)", "package_ndc": "69292-208-01", "marketing_start_date": "20191122"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69292-208-50)", "package_ndc": "69292-208-50", "marketing_start_date": "20191122"}], "brand_name": "metronidazole", "product_id": "69292-208_7287076f-6345-40c4-8ced-5b3cae45b7a4", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "69292-208", "generic_name": "metronidazole", "labeler_name": "AMICI PHARMA INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/1"}], "application_number": "ANDA070772", "marketing_category": "ANDA", "marketing_start_date": "20191122", "listing_expiration_date": "20261231"}