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

HYQVIA by

Drug Labeling and Warnings

HYQVIA by is a Other medication manufactured, distributed, or labeled by Bamboo US BidCo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HYQVIA- immune globulin infusion 10% (human) with recombinant human hyaluronidase 
Bamboo US BidCo LLC

----------

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

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

IG

LE-07-54397

Takeda

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

HY

1.25 mL
160 units per mL

Takeda

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 - 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

IG

LE-07-54409

Takeda

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

HY

2.5 mL
160 units per mL

Takeda

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 - 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

IG

LE-07-54412

Takeda

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

HY

Takeda

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 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

HY

10 mL
160 units per mL

LE-07-54417

Takeda

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

HY

15 mL
160 units per mL

LE-07-54420

Takeda

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

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

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

Inactive Ingredients
Ingredient Name	Strength
GLYCINE (UNII: TE7660XO1C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA125402	09/12/2014	06/06/2023

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

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

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

Inactive Ingredients
Ingredient Name	Strength
GLYCINE (UNII: TE7660XO1C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA125402	09/12/2014	02/26/2024

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

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

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

Inactive Ingredients
Ingredient Name	Strength
GLYCINE (UNII: TE7660XO1C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA125402	09/12/2014	05/17/2022

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

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

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

Inactive Ingredients
Ingredient Name	Strength
GLYCINE (UNII: TE7660XO1C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
BLA	BLA125402	09/12/2014	10/10/2023

Labeler - Bamboo US BidCo LLC (119087615)

Revised: 6/2025

Document Id: 37ef01b8-d892-9e28-e063-6394a90aa31f

60683-0

Set id: 1a52ca88-a13c-7c67-e063-6394a90a1f67

Version: 4

Effective Time: 20250619