NDC Code(s) : 0169-7825-01, 0169-7850-01, 0169-7810-01, 0169-7815-01, 0169-7820-01, 0169-7830-01
Packager : Novo Nordisk

Category : PLASMA DERIVATIVE

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NOVOEIGHT(antihemophilic factor, recombinant) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0169-7825
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)18 mg in 1 mL
HISTIDINE(UNII: 4QD397987E)1.5 mg in 1 mL
SUCROSE(UNII: C151H8M554)3 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
METHIONINE(UNII: AE28F7PNPL)0.055 mg in 1 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)0.25 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-7825-011 in 1 KIT 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 BLA125466 04/01/2015
NOVOEIGHT(antihemophilic factor, recombinant) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0169-7850
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)18 mg in 1 mL
HISTIDINE(UNII: 4QD397987E)1.5 mg in 1 mL
SUCROSE(UNII: C151H8M554)3 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
METHIONINE(UNII: AE28F7PNPL)0.055 mg in 1 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)0.25 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-7850-011 in 1 KIT 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 BLA125466 04/01/2015
NOVOEIGHT(antihemophilic factor, recombinant) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0169-7810
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)18 mg in 1 mL
HISTIDINE(UNII: 4QD397987E)1.5 mg in 1 mL
SUCROSE(UNII: C151H8M554)3 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
METHIONINE(UNII: AE28F7PNPL)0.055 mg in 1 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)0.25 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-7810-011 in 1 KIT 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 BLA125466 04/01/2015
NOVOEIGHT(antihemophilic factor, recombinant) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0169-7815
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)18 mg in 1 mL
HISTIDINE(UNII: 4QD397987E)1.5 mg in 1 mL
SUCROSE(UNII: C151H8M554)3 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
METHIONINE(UNII: AE28F7PNPL)0.055 mg in 1 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)0.25 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-7815-011 in 1 KIT 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 BLA125466 04/01/2015
NOVOEIGHT(antihemophilic factor, recombinant) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0169-7820
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)18 mg in 1 mL
HISTIDINE(UNII: 4QD397987E)1.5 mg in 1 mL
SUCROSE(UNII: C151H8M554)3 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
METHIONINE(UNII: AE28F7PNPL)0.055 mg in 1 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)0.25 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-7820-011 in 1 KIT 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 BLA125466 04/01/2015
NOVOEIGHT(antihemophilic factor, recombinant) KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0169-7830
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)18 mg in 1 mL
HISTIDINE(UNII: 4QD397987E)1.5 mg in 1 mL
SUCROSE(UNII: C151H8M554)3 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
METHIONINE(UNII: AE28F7PNPL)0.055 mg in 1 mL
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)0.25 mg in 1 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0169-7830-011 in 1 KIT 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 BLA125466 04/01/2015

LABELER - Novo Nordisk(622920320)

PRINCIPAL DISPLAY PANEL

250 IU Carton

NDC 0169 7825 01 List: 782501

Novoeight®

Antihemophilic Factor (Recombinant)

250 IU

Intravenous use, after reconstitution

Single dose. Discard unused portion.

Contains no preservatives

Rx Only

Includes MixPro®

a vial adapter and pre-filled diluent syringe

Image of 250 IU Carton

PRINCIPAL DISPLAY PANEL

NDC 0169 7850 01 List: 785001

Novoeight®

Antihemophilic Factor (Recombinant)

500 IU

Intravenous use, after reconstitution

Single dose. Discard unused portion.

Contains no preservatives

Rx Only

Includes MixPro®

a vial adapter and pre-filled diluent syringe

Image of 500 IU carton

PRINCIPAL DISPLAY PANEL

NDC 0169 7810 01 List: 781001

Novoeight®

Antihemophilic Factor (Recombinant)

1000 IU

Intravenous use, after reconstitution

Single dose. Discard unused portion.

Contains no preservatives

Rx Only

Includes MixPro®

a vial adapter and pre-filled diluent syringe

Image of 1000 IU carton

PRINCIPAL DISPLAY PANEL

NDC 0169 7815 01 List: 781501

Novoeight®

Antihemophilic Factor (Recombinant)

1500 IU

Intravenous use, after reconstitution

Single dose. Discard unused portion.

Contains no preservatives

Rx Only

Includes MixPro®

a vial adapter and pre-filled diluent syringe

Image of 1500 IU carton

PRINCIPAL DISPLAY PANEL

NDC 0169 7820 01 List: 782001

Novoeight®

Antihemophilic Factor (Recombinant)

2000 IU

Intravenous use, after reconstitution

Single dose. Discard unused portion.

Contains no preservatives

Rx Only

Includes MixPro®

a vial adapter and pre-filled diluent syringe

Image of 2000 IU carton

PRINCIPAL DISPLAY PANEL

NDC 0169 7830 01 List: 783001

Novoeight®

Antihemophilic Factor (Recombinant)

3000 IU

Intravenous use, after reconstitution

Single dose. Discard unused portion.

Contains no preservatives

Rx Only

Includes MixPro®

a vial adapter and pre-filled diluent syringe

Image of 3000 IU carton

PRINCIPAL DISPLAY PANEL

NDC 0169 7829 11

Novoeight®

Antihemophilic Factor

(Recombinant)

Store in a refrigerator 36°F -

46°F (2-8°C)

250 IU Vial Label

PRINCIPAL DISPLAY PANEL

NDC 0169 7851 11

Novoeight®

Antihemophilic Factor

(Recombinant)

Store in a refrigerator 36°F -

46°F (2-8°C)

500 IU Vial

PRINCIPAL DISPLAY PANEL

NDC 0169 7811 11

Novoeight®

Antihemophilic Factor

(Recombinant)

Store in a refrigerator 36°F -

46°F (2-8°C)

1000 IU Vial

PRINCIPAL DISPLAY PANEL

NDC 0169 7855 11

Novoeight®

Antihemophilic Factor

(Recombinant)

Store in a refrigerator 36°F -

46°F (2-8°C)

1500 IU Vial

PRINCIPAL DISPLAY PANEL

NDC 0169 7821 11

Novoeight®

Antihemophilic Factor

(Recombinant)

Store in a refrigerator 36°F -

46°F (2-8°C)

2000 IU Vial

PRINCIPAL DISPLAY PANEL

NDC 0169 7831 11

Novoeight®

Antihemophilic Factor

(Recombinant)

Store in a refrigerator 36°F -

46°F (2-8°C)

3000 IU Vial

PRINCIPAL DISPLAY PANEL

NDC 0169 7008 98

Sodium Chloride Solution

For reconstitution of Novoeight®

Store in a refrigerator 36°F to 46°F (2°C to 8°C)

Do not freeze

Rx Only

Single Use Only

Syringe Label