febuxostat

Generic: febuxostat tablets 80 mg

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat tablets 80 mg
Labeler macleods pharmaceuticals limited
Dosage Form FILM
Routes
ORAL
Active Ingredients

febuxostat 80 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-275
Product ID 33342-275_eb38172a-f884-4a94-be6d-73ad338fb29c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207293
Listing Expiration 2026-12-31
Marketing Start 2019-04-04

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 33342275
Hyphenated Format 33342-275

Supplemental Identifiers

RxCUI
834235 834241
UPC
0333342274151 0333342275158 0333342275073 0333342274076 0333342275103 0333342274106
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 tablets 80 mg (source: ndc)
Application Number ANDA207293 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 30 FILM in 1 BOTTLE (33342-275-07)
  • 90 FILM in 1 BOTTLE (33342-275-10)
  • 500 FILM in 1 BOTTLE (33342-275-15)
source: ndc

Packages (3)

33342-275-07 30 FILM in 1 BOTTLE (33342-275-07) 33342-275-10 90 FILM in 1 BOTTLE (33342-275-10) 33342-275-15 500 FILM in 1 BOTTLE (33342-275-15)

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": "eb38172a-f884-4a94-be6d-73ad338fb29c", "openfda": {"nui": ["N0000175698", "N0000000206"], "upc": ["0333342274151", "0333342275158", "0333342275073", "0333342274076", "0333342275103", "0333342274106"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["77875ed1-049e-421b-a8d5-569b4af4a1b5"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 FILM in 1 BOTTLE (33342-275-07)", "package_ndc": "33342-275-07", "marketing_start_date": "20190404"}, {"sample": false, "description": "90 FILM in 1 BOTTLE (33342-275-10)", "package_ndc": "33342-275-10", "marketing_start_date": "20190404"}, {"sample": false, "description": "500 FILM in 1 BOTTLE (33342-275-15)", "package_ndc": "33342-275-15", "marketing_start_date": "20190404"}], "brand_name": "Febuxostat", "product_id": "33342-275_eb38172a-f884-4a94-be6d-73ad338fb29c", "dosage_form": "FILM", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "33342-275", "generic_name": "Febuxostat tablets 80 mg", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "80 mg/1"}], "application_number": "ANDA207293", "marketing_category": "ANDA", "marketing_start_date": "20190404", "listing_expiration_date": "20261231"}