Vaccine Information: SPIKEVAX

SPIKEVAX- elasomeran injection, suspension
Catalent Indiana, LLC

256-100-000 Carton
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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
# 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 provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

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