febuxostat

Generic: febuxostat

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler lannett company, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

febuxostat 80 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-2248
Product ID 0527-2248_0f0d0dad-f491-e7e1-e063-6294a90a1e13
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213069
Listing Expiration 2026-12-31
Marketing Start 2020-06-02

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 05272248
Hyphenated Format 0527-2248

Supplemental Identifiers

RxCUI
834235 834241
UPC
0305272248328
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 ANDA213069 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0527-2248-32)
source: ndc

Packages (1)

0527-2248-32 30 TABLET in 1 BOTTLE (0527-2248-32)

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": "0f0d0dad-f491-e7e1-e063-6294a90a1e13", "openfda": {"nui": ["N0000175698", "N0000000206"], "upc": ["0305272248328"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["73b07a94-c044-42dc-abe4-7d7c860c9638"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0527-2248-32)", "package_ndc": "0527-2248-32", "marketing_start_date": "20200602"}], "brand_name": "FEBUXOSTAT", "product_id": "0527-2248_0f0d0dad-f491-e7e1-e063-6294a90a1e13", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "0527-2248", "generic_name": "febuxostat", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FEBUXOSTAT", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "80 mg/1"}], "application_number": "ANDA213069", "marketing_category": "ANDA", "marketing_start_date": "20200602", "listing_expiration_date": "20261231"}