febuxostat

Generic: febuxostat

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

febuxostat 40 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1552
Product ID 70771-1552_2a9fa82f-de69-4251-8560-5a59d41356b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205443
Listing Expiration 2026-12-31
Marketing Start 2023-03-31

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 707711552
Hyphenated Format 70771-1552

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 ANDA205443 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70771-1552-0)
  • 100 TABLET in 1 BOTTLE (70771-1552-1)
  • 30 TABLET in 1 BOTTLE (70771-1552-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1552-4) / 10 TABLET in 1 BLISTER PACK
  • 500 TABLET in 1 BOTTLE (70771-1552-5)
  • 90 TABLET in 1 BOTTLE (70771-1552-9)
source: ndc

Packages (6)

70771-1552-0 1000 TABLET in 1 BOTTLE (70771-1552-0) 70771-1552-1 100 TABLET in 1 BOTTLE (70771-1552-1) 70771-1552-3 30 TABLET in 1 BOTTLE (70771-1552-3) 70771-1552-4 10 BLISTER PACK in 1 CARTON (70771-1552-4) / 10 TABLET in 1 BLISTER PACK 70771-1552-5 500 TABLET in 1 BOTTLE (70771-1552-5) 70771-1552-9 90 TABLET in 1 BOTTLE (70771-1552-9)

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": "2a9fa82f-de69-4251-8560-5a59d41356b7", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["0629ab39-196e-4198-902a-3c16277ba205"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1552-0)", "package_ndc": "70771-1552-0", "marketing_start_date": "20230331"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1552-1)", "package_ndc": "70771-1552-1", "marketing_start_date": "20230331"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70771-1552-3)", "package_ndc": "70771-1552-3", "marketing_start_date": "20230331"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1552-4)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70771-1552-4", "marketing_start_date": "20230331"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70771-1552-5)", "package_ndc": "70771-1552-5", "marketing_start_date": "20230331"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70771-1552-9)", "package_ndc": "70771-1552-9", "marketing_start_date": "20230331"}], "brand_name": "febuxostat", "product_id": "70771-1552_2a9fa82f-de69-4251-8560-5a59d41356b7", "dosage_form": "TABLET", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "70771-1552", "generic_name": "febuxostat", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "40 mg/1"}], "application_number": "ANDA205443", "marketing_category": "ANDA", "marketing_start_date": "20230331", "listing_expiration_date": "20261231"}