febuxostat

Generic: febuxostat

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

febuxostat 40 mg/1

Manufacturer
MAJOR PHARMACEUTICALS

Identifiers & Regulatory

Product NDC 0904-7395
Product ID 0904-7395_2a8a681c-a419-43c5-b5ba-f6596aeb6677
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210461
Listing Expiration 2026-12-31
Marketing Start 2019-12-30

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 09047395
Hyphenated Format 0904-7395

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 ANDA210461 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0904-7395-46)
source: ndc

Packages (1)

0904-7395-46 30 TABLET, FILM COATED in 1 BOTTLE (0904-7395-46)

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": "2a8a681c-a419-43c5-b5ba-f6596aeb6677", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["13a80059-46f7-4453-ab37-72744657a08a"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["MAJOR PHARMACEUTICALS"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0904-7395-46)", "package_ndc": "0904-7395-46", "marketing_start_date": "20231201"}], "brand_name": "Febuxostat", "product_id": "0904-7395_2a8a681c-a419-43c5-b5ba-f6596aeb6677", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "0904-7395", "generic_name": "Febuxostat", "labeler_name": "MAJOR PHARMACEUTICALS", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "40 mg/1"}], "application_number": "ANDA210461", "marketing_category": "ANDA", "marketing_start_date": "20191230", "listing_expiration_date": "20261231"}