Febuxostat (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-40mg

NDC 47335-721-83

Febuxostat Tablets

40 mg

PHARMACIST: Please dispense with Medication Guide provided separately to each patient.

Rx only

30 Tablets

SUN PHARMA

spl-febuxostat-40mg
(click image for full-size original)
spl-febuxostat-40mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-80mg

NDC 47335-722-83

Febuxostat Tablets

80 mg

PHARMACIST: Please dispense with Medication Guide provided separately to each patient.

Rx only

30 Tablets

SUN PHARMA

spl-febuxostat-80mg
(click image for full-size original)
spl-febuxostat-80mg
FEBUXOSTAT febuxostat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-721
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
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
HYDROXYPROPYL CELLULOSE (90000 WAMW)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TALC
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FERRIC OXIDE YELLOW
Product Characteristics
Color GREEN Score no score
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code 721
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-721-83 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:47335-721-81 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:47335-721-13 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205467 07/05/2019
FEBUXOSTAT febuxostat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-722
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
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
HYDROXYPROPYL CELLULOSE (90000 WAMW)
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TALC
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FERRIC OXIDE YELLOW
Product Characteristics
Color GREEN Score no score
Shape OVAL (biconvex) Size 15mm
Flavor Imprint Code 722
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47335-722-83 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:47335-722-88 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:47335-722-18 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205467 07/05/2019
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 650445203 ANALYSIS (47335-721), ANALYSIS (47335-722), MANUFACTURE (47335-721), MANUFACTURE (47335-722)

Revised: 07/2019 Sun Pharmaceutical Industries, Inc.

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