FDA.reportPublic FDA data

HYQVIA

Manufacturer
Bamboo US BidCo LLC
Effective date
2024-12-17
Label type
PLASMA DERIVATIVE
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:45:32

Label at a glance#

ProductHYQVIA
Active ingredientHUMAN IMMUNOGLOBULIN G, HYALURONIDASE (HUMAN RECOMBINANT)
Label structure11 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL - 2.5 g/25 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 2.5 g/25 mL Vial Label
PRINCIPAL DISPLAY PANEL - 2.5 g/25 mL Vial Label

PRINCIPAL DISPLAY PANEL - 1.25 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 1.25 mL Vial Label
PRINCIPAL DISPLAY PANEL - 1.25 mL Vial Label

PRINCIPAL DISPLAY PANEL - 2.5 g/25 mL Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 CartonPRINCIPAL DISPLAY PANEL - 2.5 g/25 mL Kit Carton

PRINCIPAL DISPLAY PANEL - 5 g/50 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 5 g/50 mL Vial Label
PRINCIPAL DISPLAY PANEL - 5 g/50 mL Vial Label

PRINCIPAL DISPLAY PANEL - 2.5 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 2.5 mL Vial Label
PRINCIPAL DISPLAY PANEL - 2.5 mL Vial Label

PRINCIPAL DISPLAY PANEL - 5 g/50 mL Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 CartonPRINCIPAL DISPLAY PANEL - 5 g/50 mL Kit Carton

PRINCIPAL DISPLAY PANEL - 10 g/100 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 10 g/100 mL Vial Label
PRINCIPAL DISPLAY PANEL - 10 g/100 mL Vial Label

PRINCIPAL DISPLAY PANEL - 5 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 5 mL Vial Label
PRINCIPAL DISPLAY PANEL - 5 mL Vial Label

PRINCIPAL DISPLAY PANEL - 10 g/100 mL Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 CartonPRINCIPAL DISPLAY PANEL - 10 g/100 mL Kit Carton

PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 - 10 mL Vial Label
PRINCIPAL DISPLAY PANEL - 10 mL Vial Label

PRINCIPAL DISPLAY PANEL - 15 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - 15 mL Vial Label
PRINCIPAL DISPLAY PANEL - 15 mL Vial Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-2715HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
0944-2716HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
0944-2717HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
0944-2718HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
0944-2719HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
0944-2720HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
0944-2721HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
0944-2722HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
0944-2723HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
0944-2724HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
83703-038HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
83703-039HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
83703-040HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
83703-041HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip
83703-042HYQVIA (IMMUNE GLOBULIN INFUSION 10% (HUMAN) WITH RECOMBINANT HUMAN HYALURONIDASE) KIT [BAMBOO US BIDCO LLC]3Unmatched20241219_1a52ca88-a13c-7c67-e063-6394a90a1f67.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83703-03983703-039-02
0944-27160944-2716-05
0944-27210944-2721-03
83703-04083703-040-02
0944-27170944-2717-10
0944-27220944-2722-03
83703-04183703-041-02
0944-27180944-2718-20
0944-27230944-2723-03
83703-03883703-038-02
0944-27150944-2715-25
0944-27200944-2720-03
83703-04283703-042-02
0944-27190944-2719-30
0944-27240944-2724-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCINETE7660XO1CIACT
HUMAN IMMUNOGLOBULIN G66Y330CJHSACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATESE337SVY37IACT
ALBUMIN HUMANZIF514RVZRIACT
EDETATE DISODIUM7FLD91C86KIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYALURONIDASE (HUMAN RECOMBINANT)743QUY4VD8ACTIB
GLYCINETE7660XO1CIACT
HUMAN IMMUNOGLOBULIN G66Y330CJHSACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATESE337SVY37IACT
ALBUMIN HUMANZIF514RVZRIACT
EDETATE DISODIUM7FLD91C86KIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYALURONIDASE (HUMAN RECOMBINANT)743QUY4VD8ACTIB
GLYCINETE7660XO1CIACT
HUMAN IMMUNOGLOBULIN G66Y330CJHSACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATESE337SVY37IACT
ALBUMIN HUMANZIF514RVZRIACT
EDETATE DISODIUM7FLD91C86KIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYALURONIDASE (HUMAN RECOMBINANT)743QUY4VD8ACTIB
GLYCINETE7660XO1CIACT
HUMAN IMMUNOGLOBULIN G66Y330CJHSACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATESE337SVY37IACT
ALBUMIN HUMANZIF514RVZRIACT
EDETATE DISODIUM7FLD91C86KIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYALURONIDASE (HUMAN RECOMBINANT)743QUY4VD8ACTIB
GLYCINETE7660XO1CIACT
HUMAN IMMUNOGLOBULIN G66Y330CJHSACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATESE337SVY37IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycineGLYCINEICU Medical Inc.c10a4657-cf64-4a71-a247-363dd58993bc2025-10-21Warnings, Adverse reactionsName fallback
generic name: GLYCINE
GlycineGLYCINEB. Braun Medical Inc.f4d83550-42de-44c7-b8d5-1d0debc6aec22021-04-01Warnings, Adverse reactionsName fallback
generic name: GLYCINE
GlycineGLYCINEBaxter Healthcare Corporationd4665408-04d8-4ad7-8589-708d4defb8692018-01-02Warnings, Adverse reactionsName fallback
generic name: GLYCINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.