FDA.reportPublic FDA data

SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.5 ML Prefilled Syringe, 12y+

RxCUI
2722437
RxNorm name
SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.5 ML Prefilled Syringe, 12y+
Display name
SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.5 ML Prefilled Syringe, 12y+
Full name
SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.5 ML Prefilled Syringe, 12y+
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#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

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No records found.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
f96b315c-fa57-4876-a7e5-a9b584d8e6e6SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.5 ML Prefilled Syringe, 12y+PSN10These 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
f96b315c-fa57-4876-a7e5-a9b584d8e6e60.5 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1273 OMICRON (LP.8.1) 0.1 MG/ML Prefilled SyringeSCD10These 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
f96b315c-fa57-4876-a7e5-a9b584d8e6e6SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-1273 OMICRON (LP.8.1) 0.5 ML Prefilled Syringe, 12y+SY10These 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