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
Routes
ORAL
Active Ingredients

metronidazole 250 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-428
Product ID 46708-428_68765ffa-e238-40bb-8235-4ae53fb292e9
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 46708428
Hyphenated Format 46708-428

Supplemental Identifiers

RxCUI
311681 314106
UPC
0346708429300 0346708428303
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 (46708-428-30)
  • 100 TABLET in 1 BOTTLE (46708-428-31)
  • 50 TABLET in 1 BOTTLE (46708-428-50)
  • 250 TABLET in 1 BOTTLE (46708-428-61)
  • 500 TABLET in 1 BOTTLE (46708-428-71)
  • 1000 TABLET in 1 BOTTLE (46708-428-91)
source: ndc

Packages (6)

46708-428-30 30 TABLET in 1 BOTTLE (46708-428-30) 46708-428-31 100 TABLET in 1 BOTTLE (46708-428-31) 46708-428-50 50 TABLET in 1 BOTTLE (46708-428-50) 46708-428-61 250 TABLET in 1 BOTTLE (46708-428-61) 46708-428-71 500 TABLET in 1 BOTTLE (46708-428-71) 46708-428-91 1000 TABLET in 1 BOTTLE (46708-428-91)

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": "68765ffa-e238-40bb-8235-4ae53fb292e9", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0346708429300", "0346708428303"], "unii": ["140QMO216E"], "rxcui": ["311681", "314106"], "spl_set_id": ["d7455566-16aa-488a-af2a-93b55a04c02f"], "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 in 1 BOTTLE (46708-428-30)", "package_ndc": "46708-428-30", "marketing_start_date": "20161201"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (46708-428-31)", "package_ndc": "46708-428-31", "marketing_start_date": "20161201"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE (46708-428-50)", "package_ndc": "46708-428-50", "marketing_start_date": "20161201"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (46708-428-61)", "package_ndc": "46708-428-61", "marketing_start_date": "20161201"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (46708-428-71)", "package_ndc": "46708-428-71", "marketing_start_date": "20161201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-428-91)", "package_ndc": "46708-428-91", "marketing_start_date": "20161201"}], "brand_name": "Metronidazole", "product_id": "46708-428_68765ffa-e238-40bb-8235-4ae53fb292e9", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "46708-428", "generic_name": "Metronidazole", "labeler_name": "Alembic Pharmaceuticals Limited", "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"}