febuxostat

Generic: febuxostat

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

Drug Facts

Product Profile

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

febuxostat 40 mg/1

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3760
Product ID 68071-3760_2b5d52a3-c025-680f-e063-6394a90aca3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205443
Listing Expiration 2026-12-31
Marketing Start 2023-03-31

Pharmacologic Class

Established (EPC)
xanthine oxidase inhibitor [epc]
Mechanism of Action
xanthine oxidase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713760
Hyphenated Format 68071-3760

Supplemental Identifiers

RxCUI
834235
UPC
0368071376098
UNII
101V0R1N2E
NUI
N0000175698 N0000000206

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 febuxostat (source: ndc)
Generic Name febuxostat (source: ndc)
Application Number ANDA205443 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (68071-3760-9)
source: ndc

Packages (1)

68071-3760-9 90 TABLET in 1 BOTTLE (68071-3760-9)

Ingredients (1)

febuxostat (40 mg/1)

Linked Drug Pages (1)

febuxostat ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2b5d52a3-c025-680f-e063-6394a90aca3f", "openfda": {"nui": ["N0000175698", "N0000000206"], "upc": ["0368071376098"], "unii": ["101V0R1N2E"], "rxcui": ["834235"], "spl_set_id": ["2b5d205f-30e3-33e6-e063-6394a90aa683"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (68071-3760-9)", "package_ndc": "68071-3760-9", "marketing_start_date": "20250110"}], "brand_name": "febuxostat", "product_id": "68071-3760_2b5d52a3-c025-680f-e063-6394a90aca3f", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "68071-3760", "generic_name": "febuxostat", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "40 mg/1"}], "application_number": "ANDA205443", "marketing_category": "ANDA", "marketing_start_date": "20230331", "listing_expiration_date": "20261231"}