Vaccine Information: NOVAVAX COVID-19 Vaccine, Adjuvanted

NOVAVAX COVID-19 VACCINE, ADJUVANTED- nvx-cov2373 injection, suspension
Novavax Inc.

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

vial label
(click image for full-size original)

Package/Label Display Panel – Vial Carton

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

carton label
(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
NVX-COV2373 (NVX-COV2373) NVX-COV2373 5 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
MONOBASIC POTASSIUM PHOSPHATE
POTASSIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM CHLORIDE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
POLYSORBATE 80
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
MATRIX-M1 ADJUVANT
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
Unapproved drug other 04/23/2021
Labeler — Novavax Inc. (808837520)
Registrant — Novavax Inc. (808837520)

Revised: 04/2021 Novavax Inc.

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