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

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80631-100-10                                   novavax

10 Multi-Dose Vials

(10 doses of 0.5mL)

novavax
COVID-19 Vaccine, Adjuvanted

                                                            Suspension for
                                               Intramuscular Injection

For use under Emergency Use Authorization

NOVAVAX-1

novavax                                   NDC 80631-100-01

COVID-19 Vaccine, Adjuvanted

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

Record date/time of first
puncture:

No Preservative

Date: Time:

For use under Emergency Use Authorization
See FDA-authorized Fact Sheet for dosage and
administration. Store at 2 to 8ºC (36 to 46ºF)
DO NOT FREEZE. Discard 6 hours after first
puncture when stored at 2 to 25°C (36 to 77°F)
Keep the vial in carton to protect from light
EXP: See www.NovavaxCovidVaccine.com

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

xxxxxx-xxx          GTIN 0123456789

novavax

NOVAVAX-2
NOVAVAX COVID-19 VACCINE, ADJUVANTED 
nvx-cov2373 injection, suspension
Product Information
Product TypeVACCINEItem Code (Source)NDC:80631-100
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373 (UNII: UK9AK2IN1P) (SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV2373 - UNII:UK9AK2IN1P) SARS-COV-2 SPIKE GLYCOPROTEIN VACCINE ANTIGEN NVX-COV23735 ug  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
CHOLESTEROL (UNII: 97C5T2UQ7J)  
MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80631-100-1010 in 1 CARTON
1NDC:80631-100-015 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
emergency use authorization01/31/2022
Labeler - Novavax, Inc. (808837520)

Revised: 3/2022
Document Id: 4f90853e-058c-4bec-bbc3-b37266d088fb
Set id: 5b237fbc-d58a-4ca0-a56b-f9425d14dab5
Version: 4
Effective Time: 20220307
 
Novavax, Inc.