metronidazole

Generic: metronidazole

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

Drug Facts

Product Profile

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

metronidazole 750 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-021
Product ID 46708-021_1e73c48c-80c3-4565-b11e-65e992c3c03a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090222
Listing Expiration 2026-12-31
Marketing Start 2010-05-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708021
Hyphenated Format 46708-021

Supplemental Identifiers

RxCUI
636559
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 ANDA090222 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-30)
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-31)
  • 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-50)
  • 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-71)
source: ndc

Packages (4)

46708-021-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-30) 46708-021-31 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-31) 46708-021-50 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-50) 46708-021-71 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-71)

Ingredients (1)

metronidazole (750 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": "1e73c48c-80c3-4565-b11e-65e992c3c03a", "openfda": {"nui": ["N0000175435", "M0014907"], "unii": ["140QMO216E"], "rxcui": ["636559"], "spl_set_id": ["80c79325-1ea4-46f8-b9b8-967b7640c51d"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-30)", "package_ndc": "46708-021-30", "marketing_start_date": "20100507"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-31)", "package_ndc": "46708-021-31", "marketing_start_date": "20100507"}, {"sample": false, "description": "50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-50)", "package_ndc": "46708-021-50", "marketing_start_date": "20100507"}, {"sample": false, "description": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-021-71)", "package_ndc": "46708-021-71", "marketing_start_date": "20100507"}], "brand_name": "Metronidazole", "product_id": "46708-021_1e73c48c-80c3-4565-b11e-65e992c3c03a", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "46708-021", "generic_name": "Metronidazole", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "750 mg/1"}], "application_number": "ANDA090222", "marketing_category": "ANDA", "marketing_start_date": "20100507", "listing_expiration_date": "20261231"}