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

NDC Code(s): 0944-2715-25, 0944-2716-05, 0944-2717-10, 0944-2718-20, view more
0944-2719-30, 0944-2720-03, 0944-2721-03, 0944-2722-03, 0944-2723-03, 0944-2724-03, 83703-038-02, 83703-039-02, 83703-040-02, 83703-041-02, 83703-042-02
Packager: Bamboo US BidCo LLC

Category: PLASMA DERIVATIVE
DEA Schedule: None
Marketing Status: Biologic Licensing Application

Drug Label Information

Updated June 17, 2024

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Official Label (Printer Friendly)

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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

INGREDIENTS AND APPEARANCE

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)

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Published Date (What is this?)	Version	Files
Jun 18, 2024	2 (current)	download
Jun 10, 2024	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1549687	immunoglobulin G, human 30 GM / hyaluronidase, human recombinant 2400 UNT Kit	PSN
2	1549687	{1 (15 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (300 ML immunoglobulin G, human 100 MG/ML Injection) } Pack	GPCK
3	1549687	immunoglobulin G, human 30 GM / hyaluronidase, human recombinant 2400 UNT Kit	SY
4	1549688	HYQVIA 30 GM / 300 ML Kit	PSN
5	1549688	{1 (15 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (300 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 30 G / 300 ML Kit]	BPCK
6	1549688	Hyqvia 2400 UNT per 15 ML / 30 G per 300 ML (10 % ) Kit	SY
7	1549689	immunoglobulin G, human 2.5 GM / hyaluronidase, human recombinant 200 UNT Kit	PSN
8	1549689	{1 (1.25 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (25 ML immunoglobulin G, human 100 MG/ML Injection) } Pack	GPCK
9	1549690	HYQVIA 2.5 GM / 25 ML Kit	PSN
10	1549690	{1 (1.25 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (25 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 2.5 G / 25 ML Kit]	BPCK
11	1549690	Hyqvia 200 UNT per 1.25 ML / 2.5 G per 25 ML (10 % ) Kit	SY
12	1549691	immunoglobulin G, human 5 GM / hyaluronidase, human recombinant 400 UNT Kit	PSN
13	1549691	{1 (2.5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (50 ML immunoglobulin G, human 100 MG/ML Injection) } Pack	GPCK
14	1549692	HYQVIA 5 GM / 50 ML Kit	PSN
15	1549692	{1 (2.5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (50 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 5 G / 50 ML Kit]	BPCK
16	1549692	Hyqvia 400 UNT per 2.5 ML / 5 G per 50 ML (10 % ) Kit	SY
17	1549693	immunoglobulin G, human 10 GM / hyaluronidase, human recombinant 800 UNT Kit	PSN
18	1549693	{1 (100 ML immunoglobulin G, human 100 MG/ML Injection) / 1 (5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) } Pack	GPCK
19	1549694	HYQVIA 10 GM / 100 ML Kit	PSN
20	1549694	{1 (100 ML immunoglobulin G, human 100 MG/ML Injection) / 1 (5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) } Pack [Hyqvia 10 G / 100 ML Kit]	BPCK
21	1549694	Hyqvia 800 UNT per 5 ML / 10 G per 100 ML (10 % ) Kit	SY
22	1549695	immunoglobulin G, human 20 GM / hyaluronidase, human recombinant 1600 UNT Kit	PSN
23	1549695	{1 (10 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (200 ML immunoglobulin G, human 100 MG/ML Injection) } Pack	GPCK
24	1549696	HYQVIA 20 GM / 200 ML Kit	PSN
25	1549696	{1 (10 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (200 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 20 G / 200 ML Kit]	BPCK
26	1549696	Hyqvia 1600 UNT per 10 ML / 20 G per 200 ML (10 % ) Kit	SY
27	1809414	immunoglobulin G, human 10 % in 50 ML Injection	PSN
28	1809414	50 ML immunoglobulin G, human 100 MG/ML Injection	SCD
29	1809414	immunoglobulin G, human 10 % per 50 ML Injection	SY
30	1809414	immunoglobulin G, human 5 GM per 50 ML Injection	SY
31	1809421	immunoglobulin G, human 10 % in 100 ML Injection	PSN
32	1809421	100 ML immunoglobulin G, human 100 MG/ML Injection	SCD
33	1809421	immunoglobulin G, human 10 GM per 100 ML Injection	SY
34	1809421	immunoglobulin G, human 10 % per 100 ML Injection	SY
35	1809438	immunoglobulin G, human 10 % in 25 ML Injection	PSN
36	1809438	25 ML immunoglobulin G, human 100 MG/ML Injection	SCD
37	1809438	immunoglobulin G, human 10 % per 25 ML Injection	SY
38	1809438	immunoglobulin G, human 2.5 GM per 25 ML Injection	SY
39	1809444	immunoglobulin G, human 10 % in 200 ML Injection	PSN
40	1809444	200 ML immunoglobulin G, human 100 MG/ML Injection	SCD
41	1809444	immunoglobulin G, human 10 % per 200 ML Injection	SY
42	1809444	immunoglobulin G, human 20 GM per 200 ML Injection	SY
43	1809531	hyaluronidase, human recombinant 200 UNT in 1.25 ML Injection	PSN
44	1809531	1.25 ML hyaluronidase, human recombinant 160 UNT/ML Injection	SCD
45	1809531	hyaluronidase, human recombinant 200 UNT per 1.25 ML Injection	SY
46	1809535	hyaluronidase, human recombinant 1600 UNT in 10 ML Injection	PSN
47	1809535	10 ML hyaluronidase, human recombinant 160 UNT/ML Injection	SCD
48	1809535	hyaluronidase, human recombinant 1600 UNT per 10 ML Injection	SY
49	1809538	hyaluronidase, human recombinant 2400 UNT in 15 ML Injection	PSN
50	1809538	15 ML hyaluronidase, human recombinant 160 UNT/ML Injection	SCD
51	1809538	hyaluronidase, human recombinant 2400 UNT per 15 ML Injection	SY
52	1809539	immunoglobulin G, human 10 % in 300 ML Injection	PSN
53	1809539	300 ML immunoglobulin G, human 100 MG/ML Injection	SCD
54	1809539	immunoglobulin G, human 10 % per 300 ML Injection	SY
55	1809542	hyaluronidase, human recombinant 400 UNT in 2.5 ML Injection	PSN
56	1809542	2.5 ML hyaluronidase, human recombinant 160 UNT/ML Injection	SCD
57	1809542	hyaluronidase, human recombinant 400 UNT per 2.5 ML Injection	SY
58	1809545	hyaluronidase, human recombinant 800 UNT in 5 ML Injection	PSN
59	1809545	5 ML hyaluronidase, human recombinant 160 UNT/ML Injection	SCD
60	1809545	hyaluronidase, human recombinant 800 UNT per 5 ML Injection	SY

Label: HYQVIA (immune globulin infusion 10%- human with recombinant human hyaluronidase kit

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	NDC
1	0944-2715-25
2	0944-2716-05
3	0944-2717-10
4	0944-2718-20
5	0944-2719-30
6	0944-2720-03
7	0944-2721-03
8	0944-2722-03
9	0944-2723-03
10	0944-2724-03
11	83703-038-02
12	83703-039-02
13	83703-040-02
14	83703-041-02
15	83703-042-02

Label: HYQVIA (immune globulin infusion 10%- human with recombinant human hyaluronidase kit

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

Number of versions: 2

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

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

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

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.