Vaccine Information: SPIKEVAX

SPIKEVAX- elasomeran injection, suspension
Catalent Indiana, LLC

256-100-000 Carton
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SPIKEVAX
covid-19 vaccine, mrna injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:61434-043
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ELASOMERAN (ELASOMERAN) ELASOMERAN 0.1 mg in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61434-043-02 120 CARTON in 1 CASE contains a CARTON (61434-043-01)
1 NDC:61434-043-01 10 VIAL in 1 CARTON This package is contained within the CASE (61434-043-02) and contains a VIAL (61434-043-00)
1 NDC:61434-043-00 5.5 mL in 1 VIAL This package is contained within a CARTON (61434-043-01) and a CASE (61434-043-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125752 04/01/2022
Labeler — Catalent Indiana, LLC (172209277)
Registrant — ModernaTX, Inc. (116912313)

Revised: 05/2022 Catalent Indiana, LLC

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