uloric

Generic: febuxostat

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

febuxostat 80 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-677
Product ID 64764-677_16c36a5a-2f72-4df7-aa6f-1ca27a39404f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021856
Listing Expiration 2026-12-31
Marketing Start 2009-02-13

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 64764677
Hyphenated Format 64764-677

Supplemental Identifiers

RxCUI
834235 834239 834241 834243
UPC
0364764677305
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 uloric (source: ndc)
Generic Name febuxostat (source: ndc)
Application Number NDA021856 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (64764-677-11) / 10 TABLET in 1 BLISTER PACK
  • 100 TABLET in 1 BOTTLE (64764-677-13)
  • 1000 TABLET in 1 BOTTLE (64764-677-19)
  • 30 TABLET in 1 BOTTLE (64764-677-30)
source: ndc

Packages (4)

64764-677-11 10 BLISTER PACK in 1 CARTON (64764-677-11) / 10 TABLET in 1 BLISTER PACK 64764-677-13 100 TABLET in 1 BOTTLE (64764-677-13) 64764-677-19 1000 TABLET in 1 BOTTLE (64764-677-19) 64764-677-30 30 TABLET in 1 BOTTLE (64764-677-30)

Ingredients (1)

febuxostat (80 mg/1)

Linked Drug Pages (1)

ULORIC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "16c36a5a-2f72-4df7-aa6f-1ca27a39404f", "openfda": {"nui": ["N0000175698", "N0000000206"], "upc": ["0364764677305"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834239", "834241", "834243"], "spl_set_id": ["54de10ef-fe5f-4930-b91d-6bbb04c664bd"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (64764-677-11)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "64764-677-11", "marketing_start_date": "20090213"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (64764-677-13)", "package_ndc": "64764-677-13", "marketing_start_date": "20090213"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (64764-677-19)", "package_ndc": "64764-677-19", "marketing_start_date": "20090213"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (64764-677-30)", "package_ndc": "64764-677-30", "marketing_start_date": "20090213"}], "brand_name": "ULORIC", "product_id": "64764-677_16c36a5a-2f72-4df7-aa6f-1ca27a39404f", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "64764-677", "generic_name": "febuxostat", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ULORIC", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "80 mg/1"}], "application_number": "NDA021856", "marketing_category": "NDA", "marketing_start_date": "20090213", "listing_expiration_date": "20261231"}