febuxostat

Generic: febuxostat

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler ascend laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

febuxostat 40 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-668
Product ID 67877-668_6bb4d90a-bb0d-4a30-b673-ee8273bda1b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212924
Listing Expiration 2026-12-31
Marketing Start 2021-12-08

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 67877668
Hyphenated Format 67877-668

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 ANDA212924 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (67877-668-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (67877-668-30)
  • 10 BLISTER PACK in 1 CARTON (67877-668-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 90 TABLET, FILM COATED in 1 BOTTLE (67877-668-90)
source: ndc

Packages (4)

67877-668-10 1000 TABLET, FILM COATED in 1 BOTTLE (67877-668-10) 67877-668-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-668-30) 67877-668-38 10 BLISTER PACK in 1 CARTON (67877-668-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK 67877-668-90 90 TABLET, FILM COATED in 1 BOTTLE (67877-668-90)

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": "6bb4d90a-bb0d-4a30-b673-ee8273bda1b9", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["154ad94e-b775-4a10-ab0f-2874a0782db9"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (67877-668-10)", "package_ndc": "67877-668-10", "marketing_start_date": "20211208"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (67877-668-30)", "package_ndc": "67877-668-30", "marketing_start_date": "20211208"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-668-38)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "67877-668-38", "marketing_start_date": "20211208"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (67877-668-90)", "package_ndc": "67877-668-90", "marketing_start_date": "20211208"}], "brand_name": "Febuxostat", "product_id": "67877-668_6bb4d90a-bb0d-4a30-b673-ee8273bda1b9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "67877-668", "generic_name": "Febuxostat", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "40 mg/1"}], "application_number": "ANDA212924", "marketing_category": "ANDA", "marketing_start_date": "20211208", "listing_expiration_date": "20261231"}