PRINCIPAL DISPLAY PANEL - 2.5 g/25 mL Vial Label

Immune Globulin Infusion 10% (Human)

Component of HYQVIA

Single-Use Vial

Rx Only

Takeda Pharmaceuticals U.S.A., Inc.
Lexington, MA 02421
U.S. License No. 1898

Infuse 2nd

2.5 g/
25 mL

LE-07-54397

Takeda

PRINCIPAL DISPLAY PANEL - 2.5 g/25 mL Vial Label

PRINCIPAL DISPLAY PANEL - 1.25 mL Vial Label

Recombinant Human Hyaluronidase

Component of HYQVIA

Single-Use Vial

Rx Only

Takeda Pharmaceuticals U.S.A., Inc.
Lexington, MA 02421

Infuse 1st

1.25 mL
160 units per mL

Takeda

PRINCIPAL DISPLAY PANEL - 1.25 mL Vial Label

PRINCIPAL DISPLAY PANEL - 2.5 g/25 mL Kit Carton

Immune Globulin Infusion 10% (Human)

with Recombinant Human Hyaluronidase
HYQVIA

For Subcutaneous Administration Only.

Single-use dual vial unit

Directions for use:
Read the enclosed Package Insert.

No preservative

Rx Only

2.5 g/
25 mL

Takeda

PRINCIPAL DISPLAY PANEL - 2.5 g/25 mL Kit Carton

PRINCIPAL DISPLAY PANEL - 5 g/50 mL Vial Label

Immune Globulin Infusion 10% (Human)

Component of HYQVIA

Single-Use Vial

Rx Only

Takeda Pharmaceuticals U.S.A., Inc.
Lexington, MA 02421
U.S. License No. 1898

Infuse 2nd

5 g/
50 mL

LE-07-54409

Takeda

PRINCIPAL DISPLAY PANEL - 5 g/50 mL Vial Label

PRINCIPAL DISPLAY PANEL - 2.5 mL Vial Label

Recombinant Human Hyaluronidase

Component of HYQVIA

Single-Use Vial

Rx Only

Takeda Pharmaceuticals U.S.A., Inc.
Lexington, MA 02421

Infuse 1st

2.5 mL
160 units per mL

Takeda

PRINCIPAL DISPLAY PANEL - 2.5 mL Vial Label

PRINCIPAL DISPLAY PANEL - 5 g/50 mL Kit Carton

Immune Globulin Infusion 10% (Human)

with Recombinant Human Hyaluronidase
HYQVIA

For Subcutaneous Administration Only.

Single-use dual vial unit

Directions for use:
Read the enclosed Package Insert.

No preservative

Rx Only

5 g/
50 mL

Takeda

PRINCIPAL DISPLAY PANEL - 5 g/50 mL Kit Carton

PRINCIPAL DISPLAY PANEL - 10 g/100 mL Vial Label

Immune Globulin Infusion 10% (Human)

Component of HYQVIA

Single-Use Vial

Rx Only

Takeda Pharmaceuticals U.S.A., Inc.
Lexington, MA 02421
U.S. License No. 1898

Infuse 2nd

10 g/
100 mL

LE-07-54412

Takeda

PRINCIPAL DISPLAY PANEL - 10 g/100 mL Vial Label

PRINCIPAL DISPLAY PANEL - 5 mL Vial Label

Recombinant Human Hyaluronidase

Component of HYQVIA

Single-Use Vial

Rx Only

Takeda Pharmaceuticals U.S.A., Inc.
Lexington, MA 02421

Infuse 1st

5 mL
160 units per mL

Takeda

PRINCIPAL DISPLAY PANEL - 5 mL Vial Label

PRINCIPAL DISPLAY PANEL - 10 g/100 mL Kit Carton

Immune Globulin Infusion 10% (Human)

with Recombinant Human Hyaluronidase
HYQVIA

For Subcutaneous Administration Only.

Single-use dual vial unit

Directions for use:
Read the enclosed Package Insert.

No preservative

Rx Only

10 g/
100 mL

Takeda

PRINCIPAL DISPLAY PANEL - 10 g/100 mL Kit Carton

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

Recombinant Human Hyaluronidase

Component of HYQVIA

Single-Use Vial

Rx Only

Takeda Pharmaceuticals U.S.A., Inc.
Lexington, MA 02421

Infuse 1st

10 mL
160 units per mL

LE-07-54417

Takeda

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

PRINCIPAL DISPLAY PANEL - 15 mL Vial Label

Recombinant Human Hyaluronidase

Component of HYQVIA

Single-Use Vial

Rx Only

Takeda Pharmaceuticals U.S.A., Inc.
Lexington, MA 02421

Infuse 1st

15 mL
160 units per mL

LE-07-54420

Takeda

PRINCIPAL DISPLAY PANEL - 15 mL Vial Label

HYQVIA
immune globulin infusion 10% (human) with recombinant human hyaluronidase kit

Product Information
Product Type	PLASMA DERIVATIVE	Item Code (Source)	NDC:83703-038

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83703-038-02	1 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 VIAL, GLASS	25 mL
Part 2	1 VIAL, GLASS	1.25 mL

Part 1 of 2

IMMUNE GLOBULIN INFUSION (HUMAN), 10%
human immuneglobulin g solution

Product Information
Item Code (Source)	NDC:0944-2715
Route of Administration	SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)	HUMAN IMMUNOGLOBULIN G	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCINE (UNII: TE7660XO1C)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0944-2715-25	25 mL in 1 VIAL, GLASS; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	09/12/2014

Part 2 of 2

RECOMBINANT HUMAN HYALURONIDASE
hyaluronidase (human recombinant) solution

Product Information
Item Code (Source)	NDC:0944-2720
Route of Administration	SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYALURONIDASE (HUMAN RECOMBINANT) (UNII: 743QUY4VD8) (HYALURONIDASE (HUMAN RECOMBINANT) - UNII:743QUY4VD8)	HYALURONIDASE (HUMAN RECOMBINANT)	160 [USP'U] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE (UNII: SE337SVY37)
ALBUMIN HUMAN (UNII: ZIF514RVZR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0944-2720-03	1.25 mL in 1 VIAL, GLASS; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	09/12/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	09/12/2014

HYQVIA
immune globulin infusion 10% (human) with recombinant human hyaluronidase kit

Product Information
Product Type	PLASMA DERIVATIVE	Item Code (Source)	NDC:83703-039

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83703-039-02	1 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 VIAL, GLASS	50 mL
Part 2	1 VIAL, GLASS	2.5 mL

Part 1 of 2

IMMUNE GLOBULIN INFUSION (HUMAN), 10%
human immuneglobulin g solution

Product Information
Item Code (Source)	NDC:0944-2716
Route of Administration	SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)	HUMAN IMMUNOGLOBULIN G	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCINE (UNII: TE7660XO1C)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0944-2716-05	50 mL in 1 VIAL, GLASS; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	06/04/2012

Part 2 of 2

RECOMBINANT HUMAN HYALURONIDASE
hyaluronidase (human recombinant) solution

Product Information
Item Code (Source)	NDC:0944-2721
Route of Administration	SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYALURONIDASE (HUMAN RECOMBINANT) (UNII: 743QUY4VD8) (HYALURONIDASE (HUMAN RECOMBINANT) - UNII:743QUY4VD8)	HYALURONIDASE (HUMAN RECOMBINANT)	160 [USP'U] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE (UNII: SE337SVY37)
ALBUMIN HUMAN (UNII: ZIF514RVZR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0944-2721-03	2.5 mL in 1 VIAL, GLASS; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	09/12/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	09/12/2014

HYQVIA
immune globulin infusion 10% (human) with recombinant human hyaluronidase kit

Product Information
Product Type	PLASMA DERIVATIVE	Item Code (Source)	NDC:83703-040

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83703-040-02	1 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 VIAL, GLASS	100 mL
Part 2	1 VIAL, GLASS	5 mL

Part 1 of 2

IMMUNE GLOBULIN INFUSION (HUMAN), 10%
human immuneglobulin g solution

Product Information
Item Code (Source)	NDC:0944-2717
Route of Administration	SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)	HUMAN IMMUNOGLOBULIN G	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCINE (UNII: TE7660XO1C)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0944-2717-10	100 mL in 1 VIAL, GLASS; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	06/04/2012

Part 2 of 2

RECOMBINANT HUMAN HYALURONIDASE
hyaluronidase (human recombinant) solution

Product Information
Item Code (Source)	NDC:0944-2722
Route of Administration	SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYALURONIDASE (HUMAN RECOMBINANT) (UNII: 743QUY4VD8) (HYALURONIDASE (HUMAN RECOMBINANT) - UNII:743QUY4VD8)	HYALURONIDASE (HUMAN RECOMBINANT)	160 [USP'U] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE (UNII: SE337SVY37)
ALBUMIN HUMAN (UNII: ZIF514RVZR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0944-2722-03	5 mL in 1 VIAL, GLASS; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	09/12/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	09/12/2014

HYQVIA
immune globulin infusion 10% (human) with recombinant human hyaluronidase kit

Product Information
Product Type	PLASMA DERIVATIVE	Item Code (Source)	NDC:83703-041

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83703-041-02	1 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 VIAL, GLASS	200 mL
Part 2	1 VIAL, GLASS	10 mL

Part 1 of 2

IMMUNE GLOBULIN INFUSION (HUMAN), 10%
human immuneglobulin g solution

Product Information
Item Code (Source)	NDC:0944-2718
Route of Administration	SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)	HUMAN IMMUNOGLOBULIN G	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCINE (UNII: TE7660XO1C)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	06/04/2012

Part 2 of 2

RECOMBINANT HUMAN HYALURONIDASE
hyaluronidase (human recombinant) solution

Product Information
Item Code (Source)	NDC:0944-2723
Route of Administration	SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYALURONIDASE (HUMAN RECOMBINANT) (UNII: 743QUY4VD8) (HYALURONIDASE (HUMAN RECOMBINANT) - UNII:743QUY4VD8)	HYALURONIDASE (HUMAN RECOMBINANT)	160 [USP'U] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE (UNII: SE337SVY37)
ALBUMIN HUMAN (UNII: ZIF514RVZR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	09/12/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	09/12/2014

HYQVIA
immune globulin infusion 10% (human) with recombinant human hyaluronidase kit

Product Information
Product Type	PLASMA DERIVATIVE	Item Code (Source)	NDC:83703-042

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83703-042-02	1 in 1 CARTON; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)	HUMAN IMMUNOGLOBULIN G	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCINE (UNII: TE7660XO1C)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	06/04/2012

Part 2 of 2

RECOMBINANT HUMAN HYALURONIDASE
hyaluronidase (human recombinant) solution

Product Information
Item Code (Source)	NDC:0944-2724
Route of Administration	SUBCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYALURONIDASE (HUMAN RECOMBINANT) (UNII: 743QUY4VD8) (HYALURONIDASE (HUMAN RECOMBINANT) - UNII:743QUY4VD8)	HYALURONIDASE (HUMAN RECOMBINANT)	160 [USP'U] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE (UNII: SE337SVY37)
ALBUMIN HUMAN (UNII: ZIF514RVZR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0944-2724-03	15 mL in 1 VIAL, GLASS; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	09/12/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
BLA	BLA125402	09/12/2014

Labeler - Bamboo US BidCo LLC (119087615)

These highlights do not include all the information needed to use HYQVIA safely and effectively. See full prescribing information for HYQVIA. HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution, for subcutaneous administration Initial U.S. Approval: 2014

PRINCIPAL DISPLAY PANEL - 2.5 g/25 mL Vial Label

PRINCIPAL DISPLAY PANEL - 1.25 mL Vial Label

PRINCIPAL DISPLAY PANEL - 2.5 g/25 mL Kit Carton

PRINCIPAL DISPLAY PANEL - 5 g/50 mL Vial Label

PRINCIPAL DISPLAY PANEL - 2.5 mL Vial Label

PRINCIPAL DISPLAY PANEL - 5 g/50 mL Kit Carton

PRINCIPAL DISPLAY PANEL - 10 g/100 mL Vial Label

PRINCIPAL DISPLAY PANEL - 5 mL Vial Label

PRINCIPAL DISPLAY PANEL - 10 g/100 mL Kit Carton

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

PRINCIPAL DISPLAY PANEL - 15 mL Vial Label

These highlights do not include all the information needed to use HYQVIA safely and effectively. See full prescribing information for HYQVIA.

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Solution, for subcutaneous administration
Initial U.S. Approval: 2014