NDC 71610-386

Febuxostat

Febuxostat

Febuxostat is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Febuxostat.

Product ID71610-386_0abfb22b-8115-408a-8ccd-1b38538aa1cf
NDC71610-386
Product TypeHuman Prescription Drug
Proprietary NameFebuxostat
Generic NameFebuxostat
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-10-15
Marketing CategoryANDA / ANDA
Application NumberANDA205414
Labeler NameAphena Pharma Solutions - Tennessee, LLC
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 71610-386-60

90 TABLET in 1 BOTTLE (71610-386-60)
Marketing Start Date2020-01-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-386-60 [71610038660]

Febuxostat TABLET
Marketing CategoryANDA
Application NumberANDA205414
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-10

Drug Details

Active Ingredients

IngredientStrength
FEBUXOSTAT40 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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