JHS) 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:0944-2718-20 200 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
Part 2 of 2
RECOMBINANT HUMAN HYALURONIDASE
hyaluronidase (human recombinant) solution
Product Information
Item Code (Source) NDC:0944-2723
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:0944-2723-03 10 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 09/12/2014
HYQVIA
human immuneglobulin g and hyaluronidase (human recombinant) kit
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0944-2514
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0944-2514-02 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 300 mL
Part 2 1 VIAL, GLASS 15 mL
Part 1 of 2
IMMUNE GLOBULIN INFUSION (HUMAN), 10%
human immuneglobulin g solution
Product Information
Item Code (Source) NDC:0944-2719
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:0944-2719-30 300 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 Numbe