PRODUCT INFORMATION
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0026-3822
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0026-3822-25 1 in 1 BOX; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2 NDC:0026-3822-99 1 in 1 BOX; Type 0: Not a Combination Product
QUANTITY OF PARTS
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, SINGLE-USE 2.5 mL
Part 2 1 SYRINGE 2.5 mL
Part 1 of 2
KOVALTRY
antihemophilic factor (recombinant) injection, powder, lyophilized, for solution
PRODUCT INFORMATION
Item Code (Source) NDC:0026-4822
Route of Administration INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT (UNII: P89DR4NY54) (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT - UNII:P89DR4NY54) ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT 500 [iU] in 2.5 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
GLYCINE (UNII: TE7660XO1C)
HISTIDINE (UNII: 4QD397987E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SUCROSE (UNII: C151H8M554)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0026-4822-01 2.5 mL in 1 VIAL, SINGLE-USE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2 NDC:0026-4822-99 2.5 mL in 1 VIAL, SINGLE-USE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125574 03/17/2016
Part 2 of 2
DILUENT
water solution
PRODUCT INFORMATION
Item Code (Source) NDC:0026-0426
Route of Administration INTRAVENOUS
INACTIVE INGREDIENTS
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0026-0426-02 2.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125574 03/17/2016
MARKETING INFORMATION
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125574 03/17/2016
KOVALTRY
antihemophilic factor (recombinant) kit
PRODUCT INFORMATION
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0026-3824
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0026-3824-25 1 in 1 BOX; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2 NDC:0026-3824-99 1 in 1 BOX; Type 0: Not a Combination Product&nb |
