Label: NOVAVAX COVID-19 VACCINE, ADJUVANTED- nvx-cov2373 injection, suspension

  • NDC Code(s): 80631-100-01, 80631-100-10
  • Packager: Novavax, Inc.
  • Category: VACCINE LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 7, 2022

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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
  • INGREDIENTS AND APPEARANCE
    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)