febuxostat

Generic: febuxostat

Labeler: solco healthcare us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler solco healthcare us llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

febuxostat 80 mg/1

Manufacturer
Solco Healthcare US LLC

Identifiers & Regulatory

Product NDC 43547-296
Product ID 43547-296_7125d234-570f-4c51-8e72-8202f4dc299b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206266
Listing Expiration 2026-12-31
Marketing Start 2023-08-01

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 43547296
Hyphenated Format 43547-296

Supplemental Identifiers

RxCUI
834235 834241
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 ANDA206266 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (43547-296-03)
  • 90 TABLET in 1 BOTTLE (43547-296-09)
  • 500 TABLET in 1 BOTTLE (43547-296-50)
source: ndc

Packages (3)

43547-296-03 30 TABLET in 1 BOTTLE (43547-296-03) 43547-296-09 90 TABLET in 1 BOTTLE (43547-296-09) 43547-296-50 500 TABLET in 1 BOTTLE (43547-296-50)

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": "7125d234-570f-4c51-8e72-8202f4dc299b", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["4f5f8f2b-7200-4d76-9049-11dbc6cbd2ca"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Solco Healthcare US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (43547-296-03)", "package_ndc": "43547-296-03", "marketing_start_date": "20230801"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (43547-296-09)", "package_ndc": "43547-296-09", "marketing_start_date": "20230801"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (43547-296-50)", "package_ndc": "43547-296-50", "marketing_start_date": "20230801"}], "brand_name": "FEBUXOSTAT", "product_id": "43547-296_7125d234-570f-4c51-8e72-8202f4dc299b", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "43547-296", "generic_name": "febuxostat", "labeler_name": "Solco Healthcare US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FEBUXOSTAT", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "80 mg/1"}], "application_number": "ANDA206266", "marketing_category": "ANDA", "marketing_start_date": "20230801", "listing_expiration_date": "20261231"}