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
Routes
ORAL
Active Ingredients

metronidazole 500 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-2409
Product ID 68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206560
Listing Expiration 2026-12-31
Marketing Start 2019-02-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680712409
Hyphenated Format 68071-2409

Supplemental Identifiers

RxCUI
311681
UPC
0368071240979
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 ANDA206560 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 4 TABLET in 1 BOTTLE (68071-2409-1)
  • 21 TABLET in 1 BOTTLE (68071-2409-2)
  • 30 TABLET in 1 BOTTLE (68071-2409-3)
  • 14 TABLET in 1 BOTTLE (68071-2409-4)
  • 40 TABLET in 1 BOTTLE (68071-2409-5)
  • 20 TABLET in 1 BOTTLE (68071-2409-7)
  • 28 TABLET in 1 BOTTLE (68071-2409-8)
  • 90 TABLET in 1 BOTTLE (68071-2409-9)
source: ndc

Packages (8)

68071-2409-1 4 TABLET in 1 BOTTLE (68071-2409-1) 68071-2409-2 21 TABLET in 1 BOTTLE (68071-2409-2) 68071-2409-3 30 TABLET in 1 BOTTLE (68071-2409-3) 68071-2409-4 14 TABLET in 1 BOTTLE (68071-2409-4) 68071-2409-5 40 TABLET in 1 BOTTLE (68071-2409-5) 68071-2409-7 20 TABLET in 1 BOTTLE (68071-2409-7) 68071-2409-8 28 TABLET in 1 BOTTLE (68071-2409-8) 68071-2409-9 90 TABLET in 1 BOTTLE (68071-2409-9)

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": "10f6b5cd-3cf8-e2fe-e063-6394a90a690c", "openfda": {"nui": ["N0000175435", "M0014907"], "upc": ["0368071240979"], "unii": ["140QMO216E"], "rxcui": ["311681"], "spl_set_id": ["c2dbfec8-da5b-cd2b-e053-2a95a90ad17c"], "pharm_class_cs": ["Nitroimidazoles [CS]"], "pharm_class_epc": ["Nitroimidazole Antimicrobial [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "4 TABLET in 1 BOTTLE (68071-2409-1)", "package_ndc": "68071-2409-1", "marketing_start_date": "20210521"}, {"sample": false, "description": "21 TABLET in 1 BOTTLE (68071-2409-2)", "package_ndc": "68071-2409-2", "marketing_start_date": "20210521"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68071-2409-3)", "package_ndc": "68071-2409-3", "marketing_start_date": "20210521"}, {"sample": false, "description": "14 TABLET in 1 BOTTLE (68071-2409-4)", "package_ndc": "68071-2409-4", "marketing_start_date": "20210521"}, {"sample": false, "description": "40 TABLET in 1 BOTTLE (68071-2409-5)", "package_ndc": "68071-2409-5", "marketing_start_date": "20210521"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (68071-2409-7)", "package_ndc": "68071-2409-7", "marketing_start_date": "20210521"}, {"sample": false, "description": "28 TABLET in 1 BOTTLE (68071-2409-8)", "package_ndc": "68071-2409-8", "marketing_start_date": "20210521"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-2409-9)", "package_ndc": "68071-2409-9", "marketing_start_date": "20210521"}], "brand_name": "metronidazole", "product_id": "68071-2409_10f6b5cd-3cf8-e2fe-e063-6394a90a690c", "dosage_form": "TABLET", "pharm_class": ["Nitroimidazole Antimicrobial [EPC]", "Nitroimidazoles [CS]"], "product_ndc": "68071-2409", "generic_name": "metronidazole", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "metronidazole", "active_ingredients": [{"name": "METRONIDAZOLE", "strength": "500 mg/1"}], "application_number": "ANDA206560", "marketing_category": "ANDA", "marketing_start_date": "20190223", "listing_expiration_date": "20261231"}