NDC Code(s) : 0527-2244-32, 0527-2248-32
Packager : Lannett Company, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FEBUXOSTATfebuxostat TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-2244
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEBUXOSTAT(UNII: 101V0R1N2E)
(FEBUXOSTAT - UNII:101V0R1N2E) 		FEBUXOSTAT40 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (1200000 WAMW)(UNII: U3JF91U133)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white or almost white) Score no score
Shape ROUND (round shaped) Size 9 mm
Flavor Imprint Code C33
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0527-2244-3230 in 1 BOTTLE Type 0: Not a Combination Product06/02/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213069 06/02/2020
FEBUXOSTATfebuxostat TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-2248
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEBUXOSTAT(UNII: 101V0R1N2E)
(FEBUXOSTAT - UNII:101V0R1N2E) 		FEBUXOSTAT80 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROXYPROPYL CELLULOSE (1200000 WAMW)(UNII: U3JF91U133)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL(UNII: 532B59J990)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white (white or almost white) Score no score
Shape CAPSULE (capsule-shaped) Size 14 mm
Flavor Imprint Code C32
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0527-2248-3230 in 1 BOTTLE Type 0: Not a Combination Product06/02/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213069 06/02/2020

LABELER - Lannett Company, Inc.(002277481)

Establishment
Name Address ID/FEI Business Operations
Sunshine Lake Pharma Co., Ltd. 545391443 manufacture(0527-2244, 0527-2248)

PRINCIPAL DISPLAY PANEL

NDC 0527-2244-32

30 Tablets

Febuxostat

tablets

40 mg

Rx only

40 mg

PRINCIPAL DISPLAY PANEL

NDC 0527-2248-32

30 Tablets

Febuxostat

tablets

80 mg

Rx only

80 mg​