metronidazole

Generic: metronidazole

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

Drug Facts

Product Profile

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

metronidazole 250 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-016
Product ID 62332-016_d9dfe831-5b39-4e51-bf18-3846c3469888
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079067
Listing Expiration 2026-12-31
Marketing Start 2016-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332016
Hyphenated Format 62332-016

Supplemental Identifiers

RxCUI
311681 314106
UPC
0362332016303 0362332017300
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 ANDA079067 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62332-016-30)
  • 100 TABLET in 1 BOTTLE (62332-016-31)
  • 50 TABLET in 1 BOTTLE (62332-016-50)
  • 250 TABLET in 1 BOTTLE (62332-016-61)
  • 500 TABLET in 1 BOTTLE (62332-016-71)
  • 1000 TABLET in 1 BOTTLE (62332-016-91)
source: ndc

Packages (6)

62332-016-30 30 TABLET in 1 BOTTLE (62332-016-30) 62332-016-31 100 TABLET in 1 BOTTLE (62332-016-31) 62332-016-50 50 TABLET in 1 BOTTLE (62332-016-50) 62332-016-61 250 TABLET in 1 BOTTLE (62332-016-61) 62332-016-71 500 TABLET in 1 BOTTLE (62332-016-71) 62332-016-91 1000 TABLET in 1 BOTTLE (62332-016-91)

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": "d9dfe831-5b39-4e51-bf18-3846c3469888", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0362332016303", "0362332017300"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106"], "spl_set_id": ["b1fcf023-cdfd-45b7-b4d4-ff814f33ee79"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62332-016-30)", "package_ndc": "62332-016-30", "marketing_start_date": "20161201"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (62332-016-31)", "package_ndc": "62332-016-31", "marketing_start_date": "20161201"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (62332-016-50)", "package_ndc": "62332-016-50", "marketing_start_date": "20161201"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (62332-016-61)", "package_ndc": "62332-016-61", "marketing_start_date": "20161201"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (62332-016-71)", "package_ndc": "62332-016-71", "marketing_start_date": "20161201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (62332-016-91)", "package_ndc": "62332-016-91", "marketing_start_date": "20161201"}], "brand_name": "Metronidazole", "product_id": "62332-016_d9dfe831-5b39-4e51-bf18-3846c3469888", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "62332-016", "generic_name": "Metronidazole", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "250 mg/1"}], "application_number": "ANDA079067", "marketing_category": "ANDA", "marketing_start_date": "20161201", "listing_expiration_date": "20261231"}