Label: ASTRAZENECA COVID-19 VACCINE- azd1222 injection, suspension

  • NDC Code(s): 0310-1222-10, 0310-1222-15
  • Packager: AstraZeneca Pharmaceuticals LP
  • Category: VACCINE LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated December 22, 2020

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  • Package/Label Display Panel – Vial Label

    AstraZeneca COVID-19 Vaccine                         NDC 0310-1222-10

    For use under Emergency Use Authorization

    Suspension for Intramuscular Injection

    After first use, discard after:

    6 hours at 20°-25°C (68°-77°F), or

    48 hours at 2°-8°C (36°-46°F)

    For Exp Date: see

    www.azcovid-19.com

    Multi-dose vial (10 doses of 0.5 mL)

    vial_label_5ml
  • Package/Label Display Panel – Vial Carton

    NDC 0310-1222-15

    AstraZeneca COVID-19 Vaccine

    For use under Emergency Use Authorization

    Suspension for Intramuscular Injection

    Store at 2°-8°C (36°-46°F) in original carton to protect from light.

    Do not freeze or shake. No preservative.

    Discard 6 hours after first use when held at 20°-25°C (68°-77°F).

    Discard 48 hours after first use when held at 2°-8°C (36°-46°F).

    10 Multi-dose vials

    (each vial contains 10 doses of 0.5 mL)

    AstraZeneca

    carton_label
  • INGREDIENTS AND APPEARANCE
    ASTRAZENECA COVID-19 VACCINE 
    azd1222 injection, suspension
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:0310-1222
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AZD-1222 (UNII: B5S3K2V0G8) (AZD-1222 - UNII:B5S3K2V0G8) AZD-122250000000000 {VP}  in 0.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    HISTIDINE (UNII: 4QD397987E)  
    HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0310-1222-1510 in 1 CARTON
    1NDC:0310-1222-105 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other12/22/2020
    Labeler - AstraZeneca Pharmaceuticals LP (054743190)
    Registrant - AstraZeneca PLC (230790719)