febuxostat

Generic: febuxostat

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

febuxostat 80 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-114
Product ID 59651-114_b76fce08-5430-4285-8a39-b689c97afe29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210741
Listing Expiration 2026-12-31
Marketing Start 2023-10-25

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 59651114
Hyphenated Format 59651-114

Supplemental Identifiers

RxCUI
834235 834241
UPC
0359651113301 0359651114308
UNII
101V0R1N2E
NUI
N0000175698 N0000000206

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 febuxostat (source: ndc)
Generic Name febuxostat (source: ndc)
Application Number ANDA210741 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-114-01)
  • 500 TABLET in 1 BOTTLE (59651-114-05)
  • 30 TABLET in 1 BOTTLE (59651-114-30)
  • 90 TABLET in 1 BOTTLE (59651-114-90)
source: ndc

Packages (4)

59651-114-01 100 TABLET in 1 BOTTLE (59651-114-01) 59651-114-05 500 TABLET in 1 BOTTLE (59651-114-05) 59651-114-30 30 TABLET in 1 BOTTLE (59651-114-30) 59651-114-90 90 TABLET in 1 BOTTLE (59651-114-90)

Ingredients (1)

febuxostat (80 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": "b76fce08-5430-4285-8a39-b689c97afe29", "openfda": {"nui": ["N0000175698", "N0000000206"], "upc": ["0359651113301", "0359651114308"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["04f80eb2-8171-4e18-93e4-514440e84b75"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-114-01)", "package_ndc": "59651-114-01", "marketing_start_date": "20231025"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (59651-114-05)", "package_ndc": "59651-114-05", "marketing_start_date": "20231025"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (59651-114-30)", "package_ndc": "59651-114-30", "marketing_start_date": "20231025"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (59651-114-90)", "package_ndc": "59651-114-90", "marketing_start_date": "20231025"}], "brand_name": "Febuxostat", "product_id": "59651-114_b76fce08-5430-4285-8a39-b689c97afe29", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "59651-114", "generic_name": "Febuxostat", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "80 mg/1"}], "application_number": "ANDA210741", "marketing_category": "ANDA", "marketing_start_date": "20231025", "listing_expiration_date": "20261231"}