NDC 47335-722

Febuxostat

Febuxostat

Febuxostat is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Febuxostat.

Product ID47335-722_bdb4de18-f355-4237-bf11-1745f8f998c8
NDC47335-722
Product TypeHuman Prescription Drug
Proprietary NameFebuxostat
Generic NameFebuxostat
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-07-05
Marketing CategoryANDA / ANDA
Application NumberANDA205467
Labeler NameSun Pharmaceutical Industries, Inc.
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 47335-722-18

1000 TABLET, FILM COATED in 1 BOTTLE (47335-722-18)
Marketing Start Date2019-07-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-722-18 [47335072218]

Febuxostat TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205467
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-05

NDC 47335-722-83 [47335072283]

Febuxostat TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205467
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-05

NDC 47335-722-88 [47335072288]

Febuxostat TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205467
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-05

Drug Details

Active Ingredients

IngredientStrength
FEBUXOSTAT80 mg/1

OpenFDA Data

SPL SET ID:1f7541bd-bf32-422b-b99a-89193cf193ca
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 834241
  • 834235
  • UPC Code
  • 0347335654233
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.