Single-Use Vial

Rx Only

Manufactured by:

Baxalta US Inc.

Westlake Village, CA 91362

License No. TBD

Recombinant Human Hyaluronidase 30 g Infuse 2nd Vial Label

Immune Globulin Infusion 10% (Human)

30 g/

300 mL

Component of HYQVIA
Infuse 2nd

Single-Use Vial

Rx Only

Manufactured by:

Baxalta US Inc.

Westlake Village, CA 91362

License No. TBD

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INGREDIENTS AND APPEARANCE
HYQVIA 
human immuneglobulin g and hyaluronidase (human recombinant) kit
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0944-2510
 
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0944-2510-02 1 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)  
 
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 25 mL
Part 2 1 VIAL, GLASS 1.25 mL
 
Part 1 of 2
IMMUNE GLOBULIN INFUSION (HUMAN), 10% 
human immuneglobulin g solution
 
Product Information
Item Code (Source) NDC:0944-2715
Route of Administration SUBCUTANEOUS
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS) HUMAN IMMUNOGLOBULIN G 100 mg  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
GLYCINE (UNII: TE7660XO1C)  

Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0944-2715-25 25 mL in 1 VIAL, GLASS; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)  
 
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125402 06/04/2012 
 
Part 2 of 2
RECOMBINANT HUMAN HYALURONIDASE 
hyaluronidase (human recombinant) solution
 
Product Information
Item Code (Source) NDC:0944-2720
Route of Administration SUBCUTANEOUS
 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYALURONIDASE (HUMAN RECOMBINANT) (UNII: 743QUY4VD8) (HYALURONIDASE (HUMAN RECOMBINANT) - UNII:743QUY4VD8) HYALURONIDASE (HUMAN RECOMBINANT) 160 [USP'U]  in 1 mL
 
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
ALBUMIN HUMAN (UNII: ZIF514RVZR)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  

Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0944-2720-03 1.25 mL in 1 VIAL, GLASS; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)  

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125402 09/12/2014 

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125402 09/12/2