Label: PFIZER-BIONTECH COVID-19 VACCINE- bnt162b2 injection, suspension

  • NDC Code(s): 59267-0078-1, 59267-0078-2, 59267-0078-4
  • Packager: Pfizer Manufacturing Belgium NV
  • Category: VACCINE LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 1, 2021

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  • PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Label - 0078-1

    Pfizer-BioNTech COVID-19 Vaccine
    DILUTE PRIOR TO USE
    Age 2y to < 5y
    After dilution - 10 doses of 0.2 mL
    For intramuscular use. Contains no preservative.
    For use under Emergency Use Authorization.
    After dilution store at 2 to 25°C (35 to 77°F) and
    discard after 6 hours.
    Dilution date and time:

    NDC 59267-0078-1

    PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Label - 0078-1
  • PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton Label - 0078-2

    NDC 59267-0078-2

    Pfizer-BioNTech COVID-19 Vaccine

    Suspension for Intramuscular Injection

    DILUTE PRIOR TO USE

    195 Multiple Dose Vials

    After dilution each vial contains
    10 doses of 0.2 mL
    For age 2 years to < 5 years

    BIONTECH
    Pfizer

    For storage and expiry information, see
    FDA-authorized Fact Sheet or scan QR code.
    Store in this carton to protect from light.
    MUST BE DILUTED BEFORE USE with sterile
    0.9% Sodium Chloride Injection, USP (not supplied).
    After dilution, store the vaccine at 2°C to 25°C (35°F to 77°F).
    Discard 6 hours after dilution. Contains no preservative.
    For use under Emergency Use Authorization.

    Manufactured for
    BioNTech
    Manufacturing GmbH
    An der Goldgrube 12
    55131 Mainz, Germany

    Manufactured by
    Pfizer Inc.
    New York, NY 10017

    Rx only

    GTIN: 00359267007827
    LOT/MFG:
    PAA177570

    PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton Label - 0078-2
  • PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton - 0078-4

    Pfizer-BioNTech
    COVID-19 Vaccine
    Suspension for Intramuscular Injection
    DILUTE PRIOR TO USE
    10 Multiple Dose Vials
    After dilution each vial contains
    10 doses of 0.2 mL
    For age 2 years to < 5 years

    BIONTECH
    Pfizer

    NDC 59267-0078-4

    Rx only

    PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton - 0078-4
  • INGREDIENTS AND APPEARANCE
    PFIZER-BIONTECH COVID-19 VACCINE 
    bnt162b2 injection, suspension
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:59267-0078
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ) TOZINAMERAN3 ug  in 0.2 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALC-0159 (UNII: PJH39UMU6H)  
    ALC-0315 (UNII: AVX8DX713V)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E)  
    SUCROSE (UNII: C151H8M554)  
    1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59267-0078-2195 in 1 CARTON
    1NDC:59267-0078-12 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    2NDC:59267-0078-410 in 1 CARTON
    2NDC:59267-0078-12 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    EMERGENCY USE AUTHORIZATION08/13/2021
    Labeler - Pfizer Manufacturing Belgium NV (370156507)
    Registrant - Pfizer Inc (113480771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Manufacturing Belgium NV370156507ANALYSIS(59267-0078) , MANUFACTURE(59267-0078) , PACK(59267-0078) , LABEL(59267-0078)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmacia & Upjohn Company LLC618054084ANALYSIS(59267-0078) , MANUFACTURE(59267-0078) , PACK(59267-0078) , LABEL(59267-0078)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC174350868ANALYSIS(59267-0078) , API MANUFACTURE(59267-0078)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Inc004954111ANALYSIS(59267-0078)
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