metronidazole

Generic: metronidazole

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

Drug Facts

Product Profile

Brand Name metronidazole
Generic Name metronidazole
Labeler nucare pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metronidazole 250 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3039
Product ID 68071-3039_2d53f6ea-c356-0993-e063-6294a90aa9a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203458
Listing Expiration 2026-12-31
Marketing Start 2014-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713039
Hyphenated Format 68071-3039

Supplemental Identifiers

RxCUI
314106
UPC
0368071303964
UNII
140QMO216E
NUI
N0000175435 M0014907

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 ANDA203458 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 14 TABLET, FILM COATED in 1 BOTTLE (68071-3039-1)
  • 4 TABLET, FILM COATED in 1 BOTTLE (68071-3039-4)
  • 6 TABLET, FILM COATED in 1 BOTTLE (68071-3039-6)
  • 8 TABLET, FILM COATED in 1 BOTTLE (68071-3039-8)
source: ndc

Packages (4)

68071-3039-1 14 TABLET, FILM COATED in 1 BOTTLE (68071-3039-1) 68071-3039-4 4 TABLET, FILM COATED in 1 BOTTLE (68071-3039-4) 68071-3039-6 6 TABLET, FILM COATED in 1 BOTTLE (68071-3039-6) 68071-3039-8 8 TABLET, FILM COATED in 1 BOTTLE (68071-3039-8)

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": "2d53f6ea-c356-0993-e063-6294a90aa9a9", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0368071303964"], "unii": ["140QMO216E"], "rxcui": ["314106"], "spl_set_id": ["4ab90d8e-c21f-65ac-e054-00144ff8d46c"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (68071-3039-1)", "package_ndc": "68071-3039-1", "marketing_start_date": "20170314"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (68071-3039-4)", "package_ndc": "68071-3039-4", "marketing_start_date": "20170314"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (68071-3039-6)", "package_ndc": "68071-3039-6", "marketing_start_date": "20170314"}, {"sample": false, "description": "8 TABLET, FILM COATED in 1 BOTTLE (68071-3039-8)", "package_ndc": "68071-3039-8", "marketing_start_date": "20170314"}], "brand_name": "Metronidazole", "product_id": "68071-3039_2d53f6ea-c356-0993-e063-6294a90aa9a9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "68071-3039", "generic_name": "Metronidazole", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "250 mg/1"}], "application_number": "ANDA203458", "marketing_category": "ANDA", "marketing_start_date": "20140601", "listing_expiration_date": "20261231"}