NOVAVAX COVID-19 Vaccine, Adjuvanted: Package Insert and Label Information (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80631-100-10 novavax

Novavax COVID-19 Vaccine,
Adjuvanted

Suspension for Intramuscular Injection

10 Multi-Dose VialsEach vial contains 10 doses of 0.5 mL

For use under Emergency Use Authorization

NOVAVAX-1
(click image for full-size original)

NDC 80631-100-01

Novavax COVID-19 Vaccine, Adjuvanted

Suspension for Intramuscular Injection
Multi-dose vial (10 doses of 0.5mL)

For use under Emergency Use
Authorization. Store at 2 to 8ºC
(36 to 46ºF). DO NOT FREEZE.
After first puncture, hold at 2 to 25°C
(36 to 77°F). Discard after 6 hours.
No Preservative. Protect from light.

20018470/0

Mfg. for: Novavax, Inc., Gaithersburg, MD 20878

NOVAVAX-2
(click image for full-size original)
NOVAVAX COVID-19 VACCINE, ADJUVANTED nvx-cov2373 injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:80631-100
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373 (SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373) SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373 5 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
CHOLESTEROL
MONOBASIC POTASSIUM PHOSPHATE
POTASSIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM CHLORIDE
POLYSORBATE 80
SODIUM HYDROXIDE
HYDROCHLORIC ACID
EGG PHOSPHOLIPIDS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80631-100-10 10 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (80631-100-01)
1 NDC:80631-100-01 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (80631-100-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
emergency use authorization 01/31/2022
Labeler — Novavax, Inc. (808837520)

Revised: 09/2022 Novavax, Inc.

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