CUVITRU: Package Insert and Label Information (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Label

NDC: 0944-2850-04

Immune Globulin Subcutaneous (Human) 20%
CUVITRU
Single-Dose Vial

Rx Only

2g
10 mL

Solution for Subcutaneous Administration
The vial stopper is not made with natural rubber
latex. Refrigeration: 2°C to 8°C (36°F to 46°F) for up
to 36 months. Do not freeze. Room temperature:
not to exceed 25°C (77°F) for up to 24 months.Discard unused portion.

LE-07-54775

Shire

PRINCIPAL DISPLAY PANEL -- 10 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Carton

NDC: 0944-2850-03

2g
10 mL

Immune Globulin Subcutaneous
(Human) 20%CUVITRU

Solution for Subcutaneous Administration

Single-Dose Vial

Rx Only

Shire

PRINCIPAL DISPLAY PANEL -- 10 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mL Vial Label

NDC: 0944-2850-06

Immune Globulin Subcutaneous (Human) 20%
CUVITRU
Single-Dose Vial

4g
20 mL

Solution for Subcutaneous Administration
The vial stopper is not made with natural rubber latex. Refrigeration: 2°C to 8°C (36°F to 46°F)
for up to 36 months. Do not freeze. Room temperature: not to exceed 25°C (77°F) for up to 24 months.
Discard unused portion.

BAXALTA® and CUVITRU® are trademarks of Baxalta Incorporated, a wholly owned,
indirect subsidiary of Shire plc.
Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020

Rx Only
LE-07-54777Shire

PRINCIPAL DISPLAY PANEL -- 20 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mL Vial Carton

NDC: 0944-2850-05

4g
20 mL

Immune Globulin Subcutaneous
(Human) 20%CUVITRU

Solution for Subcutaneous Administration

Single-Dose Vial

Rx Only

Shire

PRINCIPAL DISPLAY PANEL -- 20 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mL Vial Label

NDC: 0944-2850-08

Immune Globulin Subcutaneous (Human) 20%
CUVITRU
Single-Dose Vial

Rx Only

8g
40 mL

Solution for Subcutaneous Administration
The vial stopper is not made with natural rubber latex.

Refrigeration: 2°C to 8°C (36°F to 46°F) for up to 36 months.
Do not freeze.

Room temperature: not to exceed 25°C (77°F) for up to 24 months.
Discard unused portion.

BAXALTA® and CUVITRU® are trademarks of Baxalta Incorporated,
a wholly owned, indirect subsidiary of Shire plc.

Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020

LE-07-54780Shire

PRINCIPAL DISPLAY PANEL -- 40 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mL Vial Carton

NDC: 0944-2850-07

8g
40 mL

Immune Globulin Subcutaneous
(Human) 20%CUVITRU

Solution for Subcutaneous Administration

Single-Dose Vial

Rx Only

Shire

PRINCIPAL DISPLAY PANEL -- 40 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mL Vial Label

NDC: 0944-2850-10

Immune Globulin Subcutaneous (Human) 20%
CUVITRU
Single-Dose Vial

Rx Only

10g
50 mL

Solution for Subcutaneous Administration
The vial stopper is not made with natural rubber latex.

Refrigeration: 2°C to 8°C (36°F to 46°F) for up to 36 months.
Do not freeze.

Room temperature: not to exceed 25°C (77°F) for up to 24 months.
Discard unused portion.

BAXALTA® and CUVITRU® are trademarks of Baxalta Incorporated,
a wholly owned, indirect subsidiary of Shire plc.

Baxalta US Inc.
Lexington, MA 02421 USA
U.S. License No. 2020

LE-07-54782Shire

PRINCIPAL DISPLAY PANEL -- 50 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mL Vial Carton

NDC: 0944-2850-09

10g
50 mL

Immune Globulin Subcutaneous
(Human) 20%CUVITRU

Solution for Subcutaneous Administration

Single-Dose Vial

Rx Only

Shire

PRINCIPAL DISPLAY PANEL -- 50 mL Vial Carton
(click image for full-size original)
CUVITRU immune globulin subcutaneous (human) injection, solution
Product Information
Product Type Item Code (Source) NDC:0944-2850
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HUMAN IMMUNOGLOBULIN G (HUMAN IMMUNOGLOBULIN G) HUMAN IMMUNOGLOBULIN G 200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0944-2850-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (0944-2850-02)
1 NDC:0944-2850-02 5 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0944-2850-01)
2 NDC:0944-2850-03 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (0944-2850-04)
2 NDC:0944-2850-04 10 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0944-2850-03)
3 NDC:0944-2850-05 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (0944-2850-06)
3 NDC:0944-2850-06 20 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0944-2850-05)
4 NDC:0944-2850-07 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (0944-2850-08)
4 NDC:0944-2850-08 40 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (0944-2850-07)
5 NDC:0944-2850-09 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS (0944-2850-10)
5 NDC:0944-2850-10 50 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (0944-2850-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125596 10/18/2016
Labeler — Baxalta US Inc (079887619)
Establishment
Name Address ID/FEI Operations
Baxalta Belgium Manufacturing SA 370634700 MANUFACTURE (0944-2850)

Revised: 10/2021 Baxalta US Inc

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