Novavax-COVID-19 Vaccine, Adjuvanted

Package/Label Display Panel – Vial Label

NDC 80631-100-01

NOVAVAX

COVID-19 Vaccine,

Adjuvanted

Suspension for intramuscular injection
Multi-dose vial (10 doses of 0.5 mL)

Record date/time of first use:

Date: Time:

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

NDC 80631-100-10

10 Multi-Dose Vials

(each vial contains 10 doses of 0.5 mL)

NOVAVAX

COVID-19 Vaccine, Adjuvanted

suspension for
intramuscular injection

For use under Emergency Use Authorization

NOVAVAX

COVID-19 VACCINE, ADJUVANTED
nvx-cov2373 injection, suspension

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NVX-COV2373 (UNII: UK9AK2IN1P) (NVX-COV2373 - UNII:UK9AK2IN1P)	NVX-COV2373	5 ug in 0.5 mL

Ingredient Name	Strength
Inactive Ingredients
MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
MATRIX-M1 ADJUVANT (UNII: YZ7P8Y8ECX)

#	Item Code	Package Description
Packaging
1	NDC:80631-100-10	10 in 1 CARTON
1	NDC:80631-100-01	5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		04/23/2021

Labeler - Novavax Inc. (808837520)

Registrant - Novavax Inc. (808837520)

Revised: 4/2021

Document Id: 4e8ade00-65fd-48a1-b71c-c7d188141510

Set id: 5b237fbc-d58a-4ca0-a56b-f9425d14dab5

Version: 1

Effective Time: 20210423

Novavax Inc.