Vaccine Information: EVUSHELD (Page 7 of 7)

Package/Label Display Panel

tixagevimab

Injection

150 mg/1.5 mL

(100mg/mL)

For Intramuscular Use.

1.5 mL single-dose vial.

MUST ADMINISTER

WITH CILGAVIMAB

Rx only

NDC 0310-8895-01

Discard unused portion.

No preservative. Store at

2° to 8°C (36° to 46°F).

Do not freeze or shake.

Protect from light.

For use under Emergency

Use Authorization (EUA)

AstraZeneca

tixagevimab
(click image for full-size original)

Package/Label Display Panel

cilgavimab

Injection

150 mg/1.5 mL

(100mg/mL)

For Intramuscular Use.

1.5 mL single-dose vial.

MUST ADMINISTER

WITH TIXAGEVIMAB

Rx only

NDC 0310-1061-01

Discard unused portion.

No preservative. Store at

2° to 8°C (36° to 46°F).

Do not freeze or shake.

Protect from light.

For use under Emergency

Use Authorization (EUA)

AstraZeneca

cilgavimab
(click image for full-size original)

Package/Label Display Panel

NDC 0310-7442-02

EVUSHELD™

(tixagevimab) Injection

150 mg/1.5 mL

(100mg/mL)

Co-packaged with

(cilgavimab) injection

150 mg/1.5 mL

(100mg/mL)

For use under Emergency Use Authorization (EUA)

For Intramuscular Use

Keep vials in original carton to protect from light.

Discard unused portion.

Each carton contains two (2) vials:

One 1.5 mL single-dose vial of tixagevimab

One 1.5 mL single-dose vial of cilgavimab

ATTENTION HEALTHCARE PROVIDER: EACH

VIAL MUST BE ADMINISTERED SEPARATELY

BY INTRAMUSCULAR INJECTION

Refer to FDA-Authorized Fact Sheets

for Dosage and Administration.

Rx only AstraZeneca

carton
(click image for full-size original)
EVUSHELD
azd7442 kit
Product Information
Product Type VACCINE Item Code (Source) NDC:0310-7442
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-7442-02 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 1.0 mL
Part 2 1 VIAL 1.0 mL
Part 1 of 2
AZD1061
azd1061 injection, solution
Product Information
Item Code (Source) NDC:0310-1061
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CILGAVIMAB (CILGAVIMAB) CILGAVIMAB 150 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE 2.4 mg in 1.5 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE 3.0 mg in 1.5 mL
SUCROSE 123.2 mg in 1.5 mL
POLYSORBATE 80 0.6 mg in 1.5 mL
WATER 1312 mg in 1.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-1061-01 1.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Emergency Use Authorization 12/08/2021
Part 2 of 2
AZD8895
azd8895 injection, solution
Product Information
Item Code (Source) NDC:0310-8895
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIXAGEVIMAB (TIXAGEVIMAB) TIXAGEVIMAB 150 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
HISTIDINE 2.4 mg in 1.5 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE 3.0 mg in 1.5 mL
SUCROSE 123.2 mg in 1.5 mL
POLYSORBATE 80 0.6 mg in 1.5 mL
WATER 1312 mg in 1.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0310-8895-01 1.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Emergency Use Authorization 12/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Emergency Use Authorization 12/08/2021
Labeler — AstraZeneca Pharmaceuticals LP (054743190)
Registrant — AstraZeneca PLC (230790719)

Revised: 12/2021 AstraZeneca Pharmaceuticals LP

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