US License No. 1801
Peel-off sticker for patient's chart
SAVIENT™
PHARMACEUTICALS, INC.
Toll-free no.
1-888-579-7839
Revision Date 09/2010
© 2010

KRYSTEXXA
pegloticase injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54396-801
Route of Administration INTRAVENOUS DEA Schedule 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEGLOTICASE(PEGLOTICASE) PEGLOTICASE 8mg in1mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 
SODIUM CHLORIDE 
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 
WATER 
Product Characteristics
Color  Score 
Shape  Size 
Flavor  Imprint Code 
Contains 
Packaging
# NDC Package Description Multilevel Packaging
1 54396-801-01 1VIALIn1CARTON contains a VIAL
1  1mLIn1VIAL This package is contained within the CARTON(54396-801-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125293 09/14/2010 
Labeler -Savient Pharmaceuticals, Inc.(101113025)
Establishment
Name Address ID/FEI Operations
Savient Pharmaceuticals, Inc.  101113025 manufacture
Establishment
Name Address ID/FEI Operations
Biotechnology General (Israel) Limited  600004527 api manufacture