febuxostat

Generic: febuxostat

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler viona pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

febuxostat 80 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-137
Product ID 72578-137_082ca5b7-ccb9-4096-a363-a188d6f51586
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 72578137
Hyphenated Format 72578-137

Supplemental Identifiers

RxCUI
834235 834241
UPC
0372578137069 0372578136062
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 ANDA205443 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72578-137-01)
  • 500 TABLET in 1 BOTTLE (72578-137-05)
  • 30 TABLET in 1 BOTTLE (72578-137-06)
  • 1000 TABLET in 1 BOTTLE (72578-137-10)
  • 90 TABLET in 1 BOTTLE (72578-137-16)
  • 10 BLISTER PACK in 1 CARTON (72578-137-77) / 10 TABLET in 1 BLISTER PACK
source: ndc

Packages (6)

72578-137-01 100 TABLET in 1 BOTTLE (72578-137-01) 72578-137-05 500 TABLET in 1 BOTTLE (72578-137-05) 72578-137-06 30 TABLET in 1 BOTTLE (72578-137-06) 72578-137-10 1000 TABLET in 1 BOTTLE (72578-137-10) 72578-137-16 90 TABLET in 1 BOTTLE (72578-137-16) 72578-137-77 10 BLISTER PACK in 1 CARTON (72578-137-77) / 10 TABLET in 1 BLISTER PACK

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": "082ca5b7-ccb9-4096-a363-a188d6f51586", "openfda": {"nui": ["N0000175698", "N0000000206"], "upc": ["0372578137069", "0372578136062"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["b2aeb900-d792-48b2-b678-94f82d68be32"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72578-137-01)", "package_ndc": "72578-137-01", "marketing_start_date": "20230331"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72578-137-05)", "package_ndc": "72578-137-05", "marketing_start_date": "20230331"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72578-137-06)", "package_ndc": "72578-137-06", "marketing_start_date": "20230331"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (72578-137-10)", "package_ndc": "72578-137-10", "marketing_start_date": "20230331"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72578-137-16)", "package_ndc": "72578-137-16", "marketing_start_date": "20230331"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (72578-137-77)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "72578-137-77", "marketing_start_date": "20230331"}], "brand_name": "febuxostat", "product_id": "72578-137_082ca5b7-ccb9-4096-a363-a188d6f51586", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "72578-137", "generic_name": "febuxostat", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "80 mg/1"}], "application_number": "ANDA205443", "marketing_category": "ANDA", "marketing_start_date": "20230331", "listing_expiration_date": "20261231"}