NDC 60687-538

Febuxostat

Febuxostat

Febuxostat is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Febuxostat.

Product ID60687-538_ae6954a6-dd48-4925-e053-2a95a90a392b
NDC60687-538
Product TypeHuman Prescription Drug
Proprietary NameFebuxostat
Generic NameFebuxostat
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-09-15
Marketing CategoryANDA /
Application NumberANDA205467
Labeler NameAmerican Health Packaging
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 60687-538-21

30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-538-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-538-11)
Marketing Start Date2020-09-15
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0054-0413FebuxostatFebuxostat
0054-0414FebuxostatFebuxostat
0378-3925Febuxostatfebuxostat
0378-3926Febuxostatfebuxostat
14445-156FebuxostatFebuxostat
14445-157FebuxostatFebuxostat
46708-190Febuxostatfebuxostat
46708-191Febuxostatfebuxostat
47335-721FebuxostatFebuxostat
47335-722FebuxostatFebuxostat
48792-7905FEBUXOSTATfebuxostat
48792-7906FEBUXOSTATfebuxostat
51407-293FebuxostatFebuxostat
51407-294FebuxostatFebuxostat
60687-538FebuxostatFebuxostat
62332-190Febuxostatfebuxostat
62332-191Febuxostatfebuxostat
63304-864FebuxostatFebuxostat
63304-865FebuxostatFebuxostat
68071-5271FebuxostatFebuxostat
69539-035FebuxostatFebuxostat
69539-036FebuxostatFebuxostat
71610-386FebuxostatFebuxostat
71610-411FebuxostatFebuxostat
71610-450FebuxostatFebuxostat
72205-028FebuxostatFebuxostat
72205-029FebuxostatFebuxostat
21695-516ULORICfebuxostat
43353-305ULORICfebuxostat
55154-5158ULORICfebuxostat
55154-5159ULORICfebuxostat
64764-677ULORICfebuxostat
64764-918ULORICfebuxostat

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.