febuxostat

Generic: febuxostat

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

febuxostat 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-450
Product ID 71610-450_7d2d6969-3ebd-4a87-9e40-407f5d86fd65
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205414
Listing Expiration 2026-12-31
Marketing Start 2019-11-11

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 71610450
Hyphenated Format 71610-450

Supplemental Identifiers

RxCUI
834235
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 ANDA205414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (71610-450-60)
source: ndc

Packages (1)

71610-450-60 90 TABLET in 1 BOTTLE (71610-450-60)

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": "7d2d6969-3ebd-4a87-9e40-407f5d86fd65", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["101V0R1N2E"], "rxcui": ["834235"], "spl_set_id": ["bc986925-fd24-4865-997c-ede55c2faffc"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-450-60)", "package_ndc": "71610-450-60", "marketing_start_date": "20200729"}], "brand_name": "Febuxostat", "product_id": "71610-450_7d2d6969-3ebd-4a87-9e40-407f5d86fd65", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "71610-450", "generic_name": "Febuxostat", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "40 mg/1"}], "application_number": "ANDA205414", "marketing_category": "ANDA", "marketing_start_date": "20191111", "listing_expiration_date": "20261231"}