NDC 46708-191

Febuxostat

Febuxostat

Febuxostat is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Febuxostat.

Product ID46708-191_41a95424-046e-413b-a121-cd7335e67135
NDC46708-191
Product TypeHuman Prescription Drug
Proprietary NameFebuxostat
Generic NameFebuxostat
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2019-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA205421
Labeler NameAlembic Pharmaceuticals Limited
Substance NameFEBUXOSTAT
Active Ingredient Strength80 mg/1
Pharm ClassesXanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 46708-191-06

60 TABLET, COATED in 1 CARTON (46708-191-06)
Marketing Start Date2019-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-191-30 [46708019130]

Febuxostat TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205421
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01

NDC 46708-191-91 [46708019191]

Febuxostat TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205421
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01

NDC 46708-191-06 [46708019106]

Febuxostat TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205421
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01

NDC 46708-191-10 [46708019110]

Febuxostat TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205421
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01

NDC 46708-191-31 [46708019131]

Febuxostat TABLET, COATED
Marketing CategoryANDA
Application NumberANDA205421
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-01

Drug Details

Active Ingredients

IngredientStrength
FEBUXOSTAT80 mg/1

OpenFDA Data

SPL SET ID:41a95424-046e-413b-a121-cd7335e67135
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 834241
  • 834235

    • Pharmacological Class

    • Xanthine Oxidase Inhibitor [EPC]
    • Xanthine Oxidase Inhibitors [MoA]
    • Xanthine Oxidase Inhibitor [EPC]
    • Xanthine Oxidase Inhibitors [MoA]

    NDC Crossover Matching brand name "Febuxostat" or generic name "Febuxostat"

    NDCBrand NameGeneric Name
    0054-0413FebuxostatFebuxostat
    0054-0414FebuxostatFebuxostat
    0378-3925Febuxostatfebuxostat
    0378-3926Febuxostatfebuxostat
    0527-2244FEBUXOSTATfebuxostat
    0527-2248FEBUXOSTATfebuxostat
    14445-156FebuxostatFebuxostat
    14445-157FebuxostatFebuxostat
    16714-059FebuxostatFebuxostat
    16714-060FebuxostatFebuxostat
    27808-206Febuxostatfebuxostat
    27808-207Febuxostatfebuxostat
    43547-295FEBUXOSTATfebuxostat
    43547-296FEBUXOSTATfebuxostat
    46708-190Febuxostatfebuxostat
    46708-191Febuxostatfebuxostat
    47335-721FebuxostatFebuxostat
    47335-722FebuxostatFebuxostat
    48792-7905FEBUXOSTATfebuxostat
    48792-7906FEBUXOSTATfebuxostat
    51407-293FebuxostatFebuxostat
    51407-294FebuxostatFebuxostat
    55111-796FebuxostatFebuxostat
    55111-797FebuxostatFebuxostat
    60687-538FebuxostatFebuxostat
    62332-190Febuxostatfebuxostat
    62332-191Febuxostatfebuxostat
    63304-864FebuxostatFebuxostat
    63304-865FebuxostatFebuxostat
    69539-036FebuxostatFebuxostat
    69539-035FebuxostatFebuxostat
    71610-386FebuxostatFebuxostat
    71610-411FebuxostatFebuxostat
    72205-028FebuxostatFebuxostat
    72205-029FebuxostatFebuxostat
    71610-450FebuxostatFebuxostat
    68071-5271FebuxostatFebuxostat
    21695-516ULORICfebuxostat
    43353-305ULORICfebuxostat
    55154-5158ULORICfebuxostat
    55154-5159ULORICfebuxostat
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