febuxostat

Generic: febuxostat

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

Drug Facts

Product Profile

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

febuxostat 40 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc

Identifiers & Regulatory

Product NDC 0054-0413
Product ID 0054-0413_bbddff32-f902-4e38-94fb-a1b903d69ee8
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 00540413
Hyphenated Format 0054-0413

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 ANDA205414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0054-0413-13)
source: ndc

Packages (1)

0054-0413-13 30 TABLET in 1 BOTTLE (0054-0413-13)

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": "bbddff32-f902-4e38-94fb-a1b903d69ee8", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["14f1555c-2565-42c7-b3f5-dd5f03fed67a"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0054-0413-13)", "package_ndc": "0054-0413-13", "marketing_start_date": "20191111"}], "brand_name": "Febuxostat", "product_id": "0054-0413_bbddff32-f902-4e38-94fb-a1b903d69ee8", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "0054-0413", "generic_name": "Febuxostat", "labeler_name": "Hikma Pharmaceuticals USA Inc", "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"}