Febuxostat (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Febuxostat tablets 40 mg

Indoco Remedies Limited
NDC 14445-156 -30
Febuxostat tablets
40mg
30 TabletsRx Only

40mg-30s
(click image for full-size original)

40mg-30s

Febuxostat tablets 80 mg

Indoco Remedies Limited
NDC 14445-157 -30
Febuxostat tablets
80mg
30 TabletsRx Only

80mg-30s
(click image for full-size original)
FEBUXOSTAT febuxostat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:14445-156
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEBUXOSTAT (FEBUXOSTAT) FEBUXOSTAT 40 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
TALC
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
Product Characteristics
Color GREEN (light green to green coloured) Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code 18;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14445-156-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:14445-156-90 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:14445-156-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210292 02/14/2017
FEBUXOSTAT febuxostat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:14445-157
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEBUXOSTAT (FEBUXOSTAT) FEBUXOSTAT 80 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
TALC
POLYVINYL ALCOHOL
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
Product Characteristics
Color GREEN (light green to green coloured) Score no score
Shape TEAR (biconvex) Size 14mm
Flavor Imprint Code 19;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14445-157-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:14445-157-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:14445-157-00 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210292 02/15/2017
Labeler — Indoco Remedies Limited (650445950)
Establishment
Name Address ID/FEI Operations
INDOCO REMEDIES LIMITED 915851870 ANALYSIS (14445-156), ANALYSIS (14445-157), MANUFACTURE (14445-156), MANUFACTURE (14445-157)

Revised: 01/2020 Indoco Remedies Limited

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