FDA.reportPublic FDA data

SPIKEVAX

Manufacturer
Catalent Indiana, LLC
Effective date
2024-11-24
Label type
VACCINE LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:48:47

Label at a glance#

ProductSPIKEVAX
Active ingredientCX-038839 OMICRON (XBB.1.5)
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

256-109-301Export Carton.jpg256-109-301Export Carton.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61434-06161434-061-00, 61434-061-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
CX-038839 OMICRON (XBB.1.5)4F9QRS7ZV2ACTIB

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.