tor (Recombinant)
Recombinant Factor VIII
with Vial Adapter
For Intravenous Use Only
Needleless Reconstitution Set
2000 Carton
PRINCIPAL DISPLAY PANEL
NDC 0026-3828-50
Kovaltry 3000 IU Range
Antihemophilic Factor (Recombinant)
Recombinant Factor VIII
with Vial Adapter
For Intravenous Use Only
Needleless Reconstitution Set
3000 Carton
INGREDIENTS AND APPEARANCE
KOVALTRY
antihemophilic factor (recombinant) kit
PRODUCT INFORMATION
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0026-3821
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0026-3821-25 1 in 1 BOX; Type 0: Not a Combination Product
2 NDC:0026-3821-99 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:0026-4821
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 250 [iU] in 2.5 mL
INACTIVE INGREDIENTS
Ingredient Name Strength
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCINE (UNII: TE7660XO1C)
HISTIDINE (UNII: 4QD397987E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SUCROSE (UNII: C151H8M554)
PACKAGING
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0026-4821-01 2.5 mL in 1 VIAL, SINGLE-USE; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2 NDC:0026-4821-99 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
|
