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

(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

(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.