Distributed by
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

ULORIC is a registered trademark of Teijin Pharma Limited registered in the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

All other trademark names are the property of their respective owners.

©2009, 2011 Takeda Pharmaceuticals America, Inc.

ULR015 R2

PRINCIPAL DISPLAY PANEL - 40 mg Blister Carton

UNIT DOSE

Rx Only

10 cards
containing
10 tablets
each

Uloric®
(febuxostat)
tablets

40 mg

FOR INSTITUTIONAL USE ONLY

THIS UNIT-DOSE PACKAGE IS NOT CHILD-RESISTANT.
IF DISPENSED FOR OUT-PATIENT USE,
A CHILD-RESISTANT CONTAINER SHOULD BE UTILIZED.

PRINCIPAL DISPLAY PANEL - 80 mg Blister Carton

UNIT DOSE

Rx Only

10 cards
containing
10 tablets
each

Uloric®
(febuxostat)
tablets

80 mg

FOR INSTITUTIONAL USE ONLY

THIS UNIT-DOSE PACKAGE IS NOT CHILD-RESISTANT.
IF DISPENSED FOR OUT-PATIENT USE,
A CHILD-RESISTANT CONTAINER SHOULD BE UTILIZED.

ULORIC
febuxostat tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64764-918
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
febuxostat(febuxostat) febuxostat 40mg
 
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate 
cellulose, microcrystalline 
hydroxypropyl cellulose 
croscarmellose sodium 
silicon dioxide 
magnesium stearate 
 
Product Characteristics
Color GREEN (light green to green)  Score no score
Shape ROUND (round shaped)  Size 9mm
Flavor  Imprint Code TAP;40 
Contains 
 
Packaging
# NDC Package Description Multilevel Packaging
1 64764-918-30 30TABLETIn1BOTTLE None
2 64764-918-90 90TABLETIn1BOTTLE None
3 64764-918-18 500TABLETIn1BOTTLE None
4 64764-918-11 10BLISTER PACKIn1CARTON contains a BLISTER PACK
4  10TABLETIn1BLISTER PACK This package is contained within the CARTON(64764-918-11)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021856 02/13/2009 

ULORIC
febuxostat tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64764-677
Route of Administration ORAL DEA Schedule 
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
febuxostat(febuxostat) febuxostat 80mg
 
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate 
cellulose, microcrystalline 
hydroxypropyl cellulose 
croscarmellose sodium 
silicon dioxide 
magnesium stearate 
 
Product Characteristics
Color GREEN (light green to green)  Score no score
Shape TEAR (teardrop shaped)  Size 14mm
Flavor  Imprint Code TAP;80 
Contains 
 
Packaging
# NDC Package Description Mult