metronidazole

Generic: metronidazole

Labeler: alembic labs llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler alembic labs llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metronidazole 500 mg/1

Manufacturer
Alembic Labs LLC

Identifiers & Regulatory

Product NDC 15955-389
Product ID 15955-389_4bc960cb-872d-43da-81eb-0dbb058cfaad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208681
Listing Expiration 2026-12-31
Marketing Start 2019-06-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 15955389
Hyphenated Format 15955-389

Supplemental Identifiers

RxCUI
311681 314106
UPC
0315955389019 0315955388012
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 ANDA208681 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (15955-389-01)
  • 500 TABLET in 1 BOTTLE (15955-389-05)
source: ndc

Packages (2)

15955-389-01 100 TABLET in 1 BOTTLE (15955-389-01) 15955-389-05 500 TABLET in 1 BOTTLE (15955-389-05)

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": "4bc960cb-872d-43da-81eb-0dbb058cfaad", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0315955389019", "0315955388012"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106"], "spl_set_id": ["86415209-5440-41da-abb8-e1a3d5051f91"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Alembic Labs LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (15955-389-01)", "package_ndc": "15955-389-01", "marketing_start_date": "20190626"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (15955-389-05)", "package_ndc": "15955-389-05", "marketing_start_date": "20190626"}], "brand_name": "Metronidazole", "product_id": "15955-389_4bc960cb-872d-43da-81eb-0dbb058cfaad", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "15955-389", "generic_name": "Metronidazole", "labeler_name": "Alembic Labs LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/1"}], "application_number": "ANDA208681", "marketing_category": "ANDA", "marketing_start_date": "20190626", "listing_expiration_date": "20261231"}