Label: SPIKEVAX- covid-19 vaccine, mrna injection, solution

  • NDC Code(s): 61434-061-00, 61434-061-01
  • Packager: Catalent Indiana, LLC
  • Category: VACCINE LABEL

Drug Label Information

Updated December 7, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • PRINCIPAL DISPLAY PANEL

    256-109-301Export Carton.jpg

  • INGREDIENTS AND APPEARANCE
    SPIKEVAX 
    covid-19 vaccine, mrna injection, solution
    Product Information
    Product TypeVACCINEItem Code (Source)NDC:61434-061
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CX-038839 OMICRON (XBB.1.5) (UNII: 4F9QRS7ZV2) (CX-038839 OMICRON (XBB.1.5) - UNII:4F9QRS7ZV2) CX-038839 OMICRON (XBB.1.5)50 ug  in 0.5 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61434-061-0110 in 1 CARTON
    1NDC:61434-061-002.5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only09/11/2023
    Labeler - Catalent Indiana, LLC (172209277)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!