Label: PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT- original and omicron ba.4/ba.5 injection, suspension

  • NDC Code(s): 59267-0565-1, 59267-0565-2, 59267-0609-1, 59267-0609-2
  • Packager: Pfizer Manufacturing Belgium NV
  • Category: VACCINE LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 15, 2022

If you are a consumer or patient please visit this version.

  • PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Label - 0565

    Pfizer-BioNTech COVID-19 Vaccine, Bivalent
    Original and Omicron BA.4/BA.5

    DILUTE PRIOR TO USE
    Age 5y to < 12y

    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 12 hours.
    Dilution date and time:

    NDC 59267-0565-1

    PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Label - 0565
  • PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton - 0565

    Pfizer-BioNTech
    COVID-19 Vaccine, Bivalent

    NDC 59267-0565-2

    Original and Omicron BA.4/BA.5
    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 5 years to < 12 years
    For use under Emergency Use Authorization.

    BIONTECH
    Pfizer
    Rx only

    PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton - 0565
  • PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Label - 0609

    Pfizer-BioNTech COVID-19 Vaccine, Bivalent
    Original and Omicron BA.4/BA.5

    DILUTE PRIOR TO USE
    Age 6m 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 12 hours.
    Dilution date and time:

    NDC 59267-0609-1

    PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Label - 0609
  • PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton - 0609

    Pfizer-BioNTech
    COVID-19 Vaccine, Bivalent

    NDC 59267-0609-2

    Original and Omicron BA.4/BA.5
    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 6 months to < 5 years
    For use under Emergency Use Authorization.

    BIONTECH
    Pfizer
    Rx only

    PRINCIPAL DISPLAY PANEL - 0.2 mL Vial Carton - 0609
  • INGREDIENTS AND APPEARANCE
    PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT 
    original and omicron ba.4/ba.5 injection, suspension
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:59267-0565
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ) TOZINAMERAN0.065 mg  in 2.6 mL
    BNT162B2 OMICRON (BA.4/BA.5) (UNII: JSV288Q5CV) (BNT162B2 OMICRON (BA.4/BA.5) - UNII:JSV288Q5CV) BNT162B2 OMICRON (BA.4/BA.5)0.065 mg  in 2.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE (UNII: PJH39UMU6H) 0.23 mg  in 2.6 mL
    ((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) (UNII: AVX8DX713V) 1.86 mg  in 2.6 mL
    TROMETHAMINE (UNII: 023C2WHX2V) 0.26 mg  in 2.6 mL
    TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E) 1.71 mg  in 2.6 mL
    SUCROSE (UNII: C151H8M554) 133.9 mg  in 2.6 mL
    1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K) 0.4 mg  in 2.6 mL
    CHOLESTEROL (UNII: 97C5T2UQ7J) 0.81 mg  in 2.6 mL
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 11.7 mg  in 2.6 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59267-0565-210 in 1 CARTON
    1NDC:59267-0565-12.6 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 AUTHORIZATION08/15/2022
    PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT 
    original and omicron ba.4/ba.5 injection, suspension
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:59267-0609
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOZINAMERAN (UNII: 5085ZFP6SJ) (TOZINAMERAN - UNII:5085ZFP6SJ) TOZINAMERAN0.02 mg  in 2.6 mL
    BNT162B2 OMICRON (BA.4/BA.5) (UNII: JSV288Q5CV) (BNT162B2 OMICRON (BA.4/BA.5) - UNII:JSV288Q5CV) BNT162B2 OMICRON (BA.4/BA.5)0.02 mg  in 2.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    2-(MPEG 2000)-N,N-DITETRADECYLACETAMIDE (UNII: PJH39UMU6H) 0.07 mg  in 2.6 mL
    ((4-HYDROXYBUTYL)AZANEDIYL)BIS(HEXANE-6,1-DIYL)BIS(2-HEXYLDECANOATE) (UNII: AVX8DX713V) 0.57 mg  in 2.6 mL
    TROMETHAMINE (UNII: 023C2WHX2V) 0.08 mg  in 2.6 mL
    TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E) 0.53 mg  in 2.6 mL
    SUCROSE (UNII: C151H8M554) 41.2 mg  in 2.6 mL
    1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE (UNII: 043IPI2M0K) 0.12 mg  in 2.6 mL
    CHOLESTEROL (UNII: 97C5T2UQ7J) 0.25 mg  in 2.6 mL
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 19.8 mg  in 2.6 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59267-0609-210 in 1 CARTON
    1NDC:59267-0609-12.6 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 AUTHORIZATION08/15/2022
    Labeler - Pfizer Manufacturing Belgium NV (370156507)
    Registrant - Pfizer Inc (113480771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Manufacturing Belgium NV370156507ANALYSIS(59267-0565, 59267-0609) , MANUFACTURE(59267-0565, 59267-0609) , PACK(59267-0565, 59267-0609) , LABEL(59267-0565, 59267-0609)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmacia & Upjohn Company LLC618054084ANALYSIS(59267-0565, 59267-0609) , MANUFACTURE(59267-0565, 59267-0609) , PACK(59267-0565, 59267-0609) , LABEL(59267-0565, 59267-0609)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioNTech Innovative Manufacturing Services GmbH537365801ANALYSIS(59267-0565, 59267-0609)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioNTech Manufacturing GmbH314382536ANALYSIS(59267-0565, 59267-0609) , API MANUFACTURE(59267-0565, 59267-0609)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioNTech Manufacturing Marburg GmbH313270335ANALYSIS(59267-0565, 59267-0609) , API MANUFACTURE(59267-0565, 59267-0609)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hospira, Inc.030606222ANALYSIS(59267-0565, 59267-0609) , MANUFACTURE(59267-0565, 59267-0609) , PACK(59267-0565, 59267-0609) , LABEL(59267-0565, 59267-0609)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC174350868ANALYSIS(59267-0565, 59267-0609) , API MANUFACTURE(59267-0565, 59267-0609)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Inc004954111ANALYSIS(59267-0565, 59267-0609)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pfizer Ireland Pharmaceuticals985586408ANALYSIS(59267-0565, 59267-0609)