NDC 14445-157

Febuxostat

Febuxostat

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

Product ID14445-157_60d6e78a-98f8-4968-ad5f-37689cc2c096
NDC14445-157
Product TypeHuman Prescription Drug
Proprietary NameFebuxostat
Generic NameFebuxostat
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-02-15
Marketing CategoryANDA / ANDA
Application NumberANDA210292
Labeler NameIndoco Remedies Limited
Substance NameFEBUXOSTAT
Active Ingredient Strength80 mg/1
Pharm ClassesXanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 14445-157-00

1000 TABLET, FILM COATED in 1 BOTTLE (14445-157-00)
Marketing Start Date2017-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 14445-157-30 [14445015730]

Febuxostat TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210292
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-15

NDC 14445-157-00 [14445015700]

Febuxostat TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210292
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-15

NDC 14445-157-01 [14445015701]

Febuxostat TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210292
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-15

Drug Details

Active Ingredients

IngredientStrength
FEBUXOSTAT80 mg/1

Pharmacological Class

  • 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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