NDC Code(s) : 0944-4622-03, 0944-4622-02, 0944-4622-01, 0944-4623-03, 0944-4623-02, 0944-4623-01, 0944-4626-03, 0944-4626-02, 0944-4626-01, 0944-4624-03, 0944-4624-02, 0944-4624-01, 0944-4627-03, 0944-4627-02, 0944-4627-01, 0944-4625-03, 0944-4625-02, 0944-4625-01, 0944-4628-03, 0944-4628-02, 0944-4628-01
Packager : Takeda Pharmaceuticals Amercia, Inc.

Category : PLASMA DERIVATIVE

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ADYNOVATEAntihemophilic Factor (Recombinant) PEGylated KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0944-4622
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE(UNII: 023C2WHX2V)
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
MANNITOL(UNII: 3OWL53L36A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)
GLUTATHIONE(UNII: GAN16C9B8O)
HISTIDINE(UNII: 4QD397987E)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)1 mL in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0944-4622-011 in 1 CARTON
1NDC:0944-4622-021 in 1 KIT
1NDC:0944-4622-031 in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125566 07/28/2016
ADYNOVATEAntihemophilic Factor (Recombinant) PEGylated KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0944-4623
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE(UNII: 023C2WHX2V)
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
MANNITOL(UNII: 3OWL53L36A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)
GLUTATHIONE(UNII: GAN16C9B8O)
HISTIDINE(UNII: 4QD397987E)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)1 mL in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0944-4623-011 in 1 CARTON
1NDC:0944-4623-021 in 1 KIT
1NDC:0944-4623-031 in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125566 11/13/2015
ADYNOVATEAntihemophilic Factor (Recombinant) PEGylated KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0944-4626
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE(UNII: 023C2WHX2V)
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
MANNITOL(UNII: 3OWL53L36A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)
GLUTATHIONE(UNII: GAN16C9B8O)
HISTIDINE(UNII: 4QD397987E)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)1 mL in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0944-4626-011 in 1 CARTON
1NDC:0944-4626-021 in 1 KIT
1NDC:0944-4626-031 in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125566 10/25/2016
ADYNOVATEAntihemophilic Factor (Recombinant) PEGylated KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0944-4624
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE(UNII: 023C2WHX2V)
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
MANNITOL(UNII: 3OWL53L36A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)
GLUTATHIONE(UNII: GAN16C9B8O)
HISTIDINE(UNII: 4QD397987E)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)1 mL in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0944-4624-011 in 1 CARTON
1NDC:0944-4624-021 in 1 KIT
1NDC:0944-4624-031 in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125566 10/25/2016
ADYNOVATEAntihemophilic Factor (Recombinant) PEGylated KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0944-4627
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE(UNII: 023C2WHX2V)
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
MANNITOL(UNII: 3OWL53L36A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)
GLUTATHIONE(UNII: GAN16C9B8O)
HISTIDINE(UNII: 4QD397987E)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)1 mL in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0944-4627-011 in 1 CARTON
1NDC:0944-4627-021 in 1 KIT
1NDC:0944-4627-031 in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125566 11/13/2015
ADYNOVATEAntihemophilic Factor (Recombinant) PEGylated KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0944-4625
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE(UNII: 023C2WHX2V)
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
MANNITOL(UNII: 3OWL53L36A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)
GLUTATHIONE(UNII: GAN16C9B8O)
HISTIDINE(UNII: 4QD397987E)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)1 mL in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0944-4625-011 in 1 CARTON
1NDC:0944-4625-021 in 1 KIT
1NDC:0944-4625-031 in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125566 11/13/2015
ADYNOVATEAntihemophilic Factor (Recombinant) PEGylated KIT
Product Information
Product Type PLASMA DERIVATIVE Item Code (Source) NDC:0944-4628
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE(UNII: 023C2WHX2V)
CALCIUM CHLORIDE(UNII: M4I0D6VV5M)
MANNITOL(UNII: 3OWL53L36A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TREHALOSE DIHYDRATE(UNII: 7YIN7J07X4)
GLUTATHIONE(UNII: GAN16C9B8O)
HISTIDINE(UNII: 4QD397987E)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)1 mL in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0944-4628-011 in 1 CARTON
1NDC:0944-4628-021 in 1 KIT
1NDC:0944-4628-031 in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125566 10/25/2016

LABELER - Takeda Pharmaceuticals Amercia, Inc.(039997266)

Establishment
Name Address ID/FEI Business Operations
BAXALTA US INC. 009471603 MANUFACTURE(0944-4622, 0944-4623, 0944-4626, 0944-4624, 0944-4627, 0944-4625, 0944-4628)

Establishment
Name Address ID/FEI Business Operations
Siegfried Hameln GmbH 315869123 MANUFACTURE(64764-514, 64764-515)

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4622-01

Single-dose only

For Intravenous Administration After Reconstitution Only

Lyophilized powder for reconstitution

ADYNOVATE and diluent preassembled in BAXJECT III system

Rx Only

Actual potency

Takeda

PRINCIPAL DISPLAY PANEL - Kit Carton - 250 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

For Intravenous Administration Only

ADYNOVATE and diluent preassembled
in BAXJECT III system

Directions for use: see package insert

Rx Only

IU:

LOT:

EXP:

Takeda

0754163

PRINCIPAL DISPLAY PANEL - Barrel Label - 250 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4622-02

Single-dose only

0760339

For Intravenous Administration Only

ADYNOVATE and diluent preassembled in BAXJECT III system

Do not open until time of use

Do not use if packaging is opened or damaged

Rx Only

Takeda

PRINCIPAL DISPLAY PANEL - Blister Label - 250 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4623-01

Single-dose only

For Intravenous Administration After Reconstitution Only

Lyophilized powder for reconstitution

ADYNOVATE and diluent preassembled in BAXJECT III system

Rx Only

Actual potency

Takeda

PRINCIPAL DISPLAY PANEL - Kit Carton - 500 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

For Intravenous Administration Only

ADYNOVATE and diluent preassembled
in BAXJECT III system

Directions for use: see package insert

Rx Only

IU:

LOT:

EXP:

Takeda

0754167

PRINCIPAL DISPLAY PANEL - Barrel Label - 500 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4623-02

Single-dose only

0760341

For Intravenous Administration Only

ADYNOVATE and diluent preassembled in BAXJECT III system

Do not open until time of use

Do not use if packaging is opened or damaged

Rx Only

Takeda

PRINCIPAL DISPLAY PANEL - Blister Label - 500 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4626-01

Single-dose only

For Intravenous Administration After Reconstitution Only

Lyophilized powder for reconstitution

ADYNOVATE and diluent preassembled in BAXJECT III system

Rx Only

Actual potency

Takeda

PRINCIPAL DISPLAY PANEL - Kit Carton - 750 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

For Intravenous Administration Only

ADYNOVATE and diluent preassembled
in BAXJECT III system

Directions for use: see package insert

Rx Only

IU:

LOT:

EXP:

Takeda

0754182

PRINCIPAL DISPLAY PANEL - Barrel Label - 750 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4626-02

Single-dose only

0760343

For Intravenous Administration Only

ADYNOVATE and diluent preassembled in BAXJECT III system

Do not open until time of use

Do not use if packaging is opened or damaged

Rx Only

Takeda

PRINCIPAL DISPLAY PANEL - Blister Label - 750 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4624-01

Single-dose only

For Intravenous Administration After Reconstitution Only

Lyophilized powder for reconstitution

ADYNOVATE and diluent preassembled in BAXJECT III system

Rx Only

Actual potency

Takeda

PRINCIPAL DISPLAY PANEL - Kit Carton - 1000 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

For Intravenous Administration Only

ADYNOVATE and diluent preassembled
in BAXJECT III system

Directions for use: see package insert

Rx Only

IU:

LOT:

EXP:

Takeda

0754170

PRINCIPAL DISPLAY PANEL - Barrel Label - 1000 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4624-02

Single-dose only

0760345

For Intravenous Administration Only

ADYNOVATE and diluent preassembled in BAXJECT III system

Do not open until time of use

Do not use if packaging is opened or damaged

Rx Only

Takeda

PRINCIPAL DISPLAY PANEL - Blister Label - 1000 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4627-01

Single-dose only

For Intravenous Administration After Reconstitution Only

Lyophilized powder for reconstitution

ADYNOVATE and diluent preassembled in BAXJECT III system

Rx Only

Actual potency

Takeda

PRINCIPAL DISPLAY PANEL - Kit Carton - 1500 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

For Intravenous Administration Only

ADYNOVATE and diluent preassembled
in BAXJECT III system

Directions for use: see package insert

Rx Only

IU:

LOT:

EXP:

Takeda

0754173

PRINCIPAL DISPLAY PANEL - Barrel Label - 1500 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4627-02

Single-dose only

0760353

For Intravenous Administration Only

ADYNOVATE and diluent preassembled in BAXJECT III system

Do not open until time of use

Do not use if packaging is opened or damaged

Rx Only

Takeda

PRINCIPAL DISPLAY PANEL - Blister Label - 1500 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4625-01

Single-dose only

Actual potency

For Intravenous Administration After Reconstitution Only

Lyophilized powder for reconstitution

ADYNOVATE and diluent preassembled in
BAXJECT III system

Rx Only

Takeda

PRINCIPAL DISPLAY PANEL - Kit Carton - 2000 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

For Intravenous Administration Only

ADYNOVATE and diluent preassembled
in BAXJECT III system

Directions for use: see package insert

Rx Only

IU:

LOT:

EXP:

Takeda

0754176

PRINCIPAL DISPLAY PANEL - Barrel Label - 2000 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4625-02

Single-dose only

0760355

For Intravenous Administration Only

ADYNOVATE and diluent preassembled in BAXJECT III system

Do not open until time of use

Do not use if packaging is opened or damaged

Rx Only

Takeda

PRINCIPAL DISPLAY PANEL - Blister Label - 2000 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4628-01

Single-dose only

Actual potency

For Intravenous Administration After Reconstitution Only

Lyophilized powder for reconstitution

ADYNOVATE and diluent preassembled in
BAXJECT III system

Rx Only

Takeda

PRINCIPAL DISPLAY PANEL - Kit Carton - 3000 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

For Intravenous Administration Only

ADYNOVATE and diluent preassembled
in BAXJECT III system

Directions for use: see package insert

Rx Only

IU:

LOT:

EXP:

Takeda

0754179

PRINCIPAL DISPLAY PANEL - Barrel Label - 3000 IU

PRINCIPAL DISPLAY PANEL

ADYNOVATE
[Antihemophilic Factor
(Recombinant), PEGylated]

NDC 0944-4628-02

Single-dose only

0760357

For Intravenous Administration Only

ADYNOVATE and diluent preassembled in BAXJECT III system

Do not open until time of use

Do not use if packaging is opened or damaged

Rx Only

Takeda

PRINCIPAL DISPLAY PANEL - Blister Label - 3000 IU

PRINCIPAL DISPLAY PANEL

Antihemophilic Factor (Recombinant), PEGylated

0754164

Takeda

Lot No.:

PRINCIPAL DISPLAY PANEL - Antihemophilic Factor Vial Label

PRINCIPAL DISPLAY PANEL

Sterile Water for Injection

Lot No.:

Siegfried Hameln GmbH

0742211

PRINCIPAL DISPLAY PANEL - Sterile Water for Injection Vial Label