asis of Strength Strength
coagulation factor IX human (coagulation factor IX human) coagulation factor IX human 100 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Histidine 0.01 mol in 1 mL
Sodium Chloride 0.066 mol in 1 mL
Mannitol 0.165 mol in 1 mL
Polysorbate 80
hydrochloric acid
sodium hydroxide
water
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0053-7668-02 1 VIAL In 1 KIT contains a VIAL
1 10 mL In 1 VIAL This package is contained within the KIT (0053-7668-02)
2 0053-7668-04 1 VIAL In 1 KIT contains a VIAL
2 20 mL In 1 VIAL This package is contained within the KIT (0053-7668-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103957 08/20/1992
Labeler - CSL Behring LLC (931896963)
Establishment
Name Address ID/FEI Operations
CSL Behring LLC 931896963 MANUFACTURE
Revised: 04/2009CSL Behring LLC
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