NDC 69539-036

Febuxostat

Febuxostat

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

Product ID69539-036_2beb5a3f-7717-420f-bcfd-ec01a7eb2e62
NDC69539-036
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 NameMSN LABORATORIES PRIVATE 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 69539-036-30

30 TABLET, FILM COATED in 1 BOTTLE (69539-036-30)
Marketing Start Date2019-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69539-036-91 [69539003691]

Febuxostat TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210461
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-30

NDC 69539-036-99 [69539003699]

Febuxostat TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210461
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-30

NDC 69539-036-30 [69539003630]

Febuxostat TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA210461
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-30

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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