febuxostat

Generic: febuxostat

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

febuxostat 40 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-538
Product ID 60687-538_102d1826-981f-0ebc-e063-6294a90a4acc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205467
Listing Expiration 2026-12-31
Marketing Start 2021-09-02

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 60687538
Hyphenated Format 60687-538

Supplemental Identifiers

RxCUI
834235
UNII
101V0R1N2E
NUI
N0000175698 N0000000206

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 ANDA205467 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-538-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-538-11)
source: ndc

Packages (1)

60687-538-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-538-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-538-11)

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": "102d1826-981f-0ebc-e063-6294a90a4acc", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["101V0R1N2E"], "rxcui": ["834235"], "spl_set_id": ["14f80ad5-37cc-4672-9caa-2dd2f469af0a"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-538-21)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-538-11)", "package_ndc": "60687-538-21", "marketing_start_date": "20210902"}], "brand_name": "Febuxostat", "product_id": "60687-538_102d1826-981f-0ebc-e063-6294a90a4acc", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "60687-538", "generic_name": "Febuxostat", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "40 mg/1"}], "application_number": "ANDA205467", "marketing_category": "ANDA", "marketing_start_date": "20210902", "listing_expiration_date": "20261231"}