SPIKEVAX- covid-19 vaccine, mrna injection, solution

SPIKEVAX by

Drug Labeling and Warnings

SPIKEVAX by is a Other medication manufactured, distributed, or labeled by Catalent Indiana, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPIKEVAX 
covid-19 vaccine, mrna injection, solution

Product Information
Product Type	VACCINE	Item Code (Source)	NDC: 61434-061
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61434-061-01	10 in 1 CARTON
1	NDC: 61434-061-00	2.5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		09/11/2023

Labeler - Catalent Indiana, LLC (172209277)