febuxostat

Generic: febuxostat

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

Drug Facts

Product Profile

Brand Name febuxostat
Generic Name febuxostat
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

febuxostat 80 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-191
Product ID 46708-191_1d0ffd95-5afe-4f03-8ac9-706187144e98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205421
Listing Expiration 2026-12-31
Marketing Start 2019-07-01

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 46708191
Hyphenated Format 46708-191

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 ANDA205421 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 60 TABLET, COATED in 1 CARTON (46708-191-06)
  • 100 TABLET, COATED in 1 CARTON (46708-191-10)
  • 30 TABLET, COATED in 1 BOTTLE (46708-191-30)
  • 100 TABLET, COATED in 1 BOTTLE (46708-191-31)
  • 1000 TABLET, COATED in 1 BOTTLE (46708-191-91)
source: ndc

Packages (5)

46708-191-06 60 TABLET, COATED in 1 CARTON (46708-191-06) 46708-191-10 100 TABLET, COATED in 1 CARTON (46708-191-10) 46708-191-30 30 TABLET, COATED in 1 BOTTLE (46708-191-30) 46708-191-31 100 TABLET, COATED in 1 BOTTLE (46708-191-31) 46708-191-91 1000 TABLET, COATED in 1 BOTTLE (46708-191-91)

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": "1d0ffd95-5afe-4f03-8ac9-706187144e98", "openfda": {"nui": ["N0000175698", "N0000000206"], "unii": ["101V0R1N2E"], "rxcui": ["834235", "834241"], "spl_set_id": ["41a95424-046e-413b-a121-cd7335e67135"], "pharm_class_epc": ["Xanthine Oxidase Inhibitor [EPC]"], "pharm_class_moa": ["Xanthine Oxidase Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, COATED in 1 CARTON (46708-191-06)", "package_ndc": "46708-191-06", "marketing_start_date": "20190701"}, {"sample": false, "description": "100 TABLET, COATED in 1 CARTON (46708-191-10)", "package_ndc": "46708-191-10", "marketing_start_date": "20190701"}, {"sample": false, "description": "30 TABLET, COATED in 1 BOTTLE (46708-191-30)", "package_ndc": "46708-191-30", "marketing_start_date": "20190701"}, {"sample": false, "description": "100 TABLET, COATED in 1 BOTTLE (46708-191-31)", "package_ndc": "46708-191-31", "marketing_start_date": "20190701"}, {"sample": false, "description": "1000 TABLET, COATED in 1 BOTTLE (46708-191-91)", "package_ndc": "46708-191-91", "marketing_start_date": "20190701"}], "brand_name": "Febuxostat", "product_id": "46708-191_1d0ffd95-5afe-4f03-8ac9-706187144e98", "dosage_form": "TABLET, COATED", "pharm_class": ["Xanthine Oxidase Inhibitor [EPC]", "Xanthine Oxidase Inhibitors [MoA]"], "product_ndc": "46708-191", "generic_name": "febuxostat", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Febuxostat", "active_ingredients": [{"name": "FEBUXOSTAT", "strength": "80 mg/1"}], "application_number": "ANDA205421", "marketing_category": "ANDA", "marketing_start_date": "20190701", "listing_expiration_date": "20261231"}