FDA.reportPublic FDA data

spikevax 2024-2025 vaccine, 0.25 ML Prefilled Syringe, 6m through 11y

RxCUI
2719760
RxNorm name
spikevax 2024-2025 vaccine, 0.25 ML Prefilled Syringe, 6m through 11y
Display name
spikevax 2024-2025 vaccine, 0.25 ML Prefilled Syringe, 6m through 11y
Full name
spikevax 2024-2025 vaccine, 0.25 ML Prefilled Syringe, 6m through 11y
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:29

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125752SpikevaxCOVID-19 Vaccine, mRNA351(a)Disc2026-07-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f96b315c-fa57-4876-a7e5-a9b584d8e6e6spikevax 2024-2025 vaccine, 0.25 ML Prefilled Syringe, 6m through 11y [PSN] · 0.25 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (KP.2) 0.1 MG/ML Prefilled Syringe [Spikevax 2024-2025] [SBD] · 0.25 ML Spikevax 2024-2025 0.1 MG/ML Prefilled Syringe [SY] · Spikevax 2024-2025 vaccine, 0.25 ML Prefilled Syringe, 6m through 11y [SY]410These highlights do not include all the information needed to use SPIKEVAX safely and effectively. See full prescribing information for SPIKEVAX . SPIKEVAX (COVID-19 Vaccine, mRNA) injectable suspension, for intramuscular use 2025-2026 Formula Initial U.S. Approval: 202220250827