NDC 68071-5271

Febuxostat

Febuxostat

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

Product ID68071-5271_a745bf94-a68e-1ec6-e053-2a95a90a9842
NDC68071-5271
Product TypeHuman Prescription Drug
Proprietary NameFebuxostat
Generic NameFebuxostat
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-12-30
Marketing CategoryANDA / ANDA
Application NumberANDA210461
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameFEBUXOSTAT
Active Ingredient Strength40 mg/1
Pharm ClassesXanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68071-5271-3

30 TABLET, FILM COATED in 1 BOTTLE (68071-5271-3)
Marketing Start Date2020-06-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-5271-3 [68071527103]

Febuxostat TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210461
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-06-04

Drug Details

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.