FDA.reportPublic FDA data

SARS-CoV-2 (COVID-19) vaccine, mRNA-1283 OMICRON (LP.8.1) 0.2 ML Prefilled Syringe

RxCUI
2722654
RxNorm name
SARS-CoV-2 (COVID-19) vaccine, mRNA-1283 OMICRON (LP.8.1) 0.2 ML Prefilled Syringe
Display name
SARS-CoV-2 (COVID-19) vaccine, mRNA-1283 OMICRON (LP.8.1) 0.2 ML Prefilled Syringe
Full name
SARS-CoV-2 (COVID-19) vaccine, mRNA-1283 OMICRON (LP.8.1) 0.2 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:09

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125835mnexspikeCOVID-19 Vaccine, mRNA351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

Reported adverse events (FAERS/openFDA)#

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

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
97c27eb6-1d2e-4953-afac-882ada70c6f8SARS-CoV-2 (COVID-19) vaccine, mRNA-1283 OMICRON (LP.8.1) 0.2 ML Prefilled Syringe [PSN] · 0.2 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-1283 OMICRON (LP.8.1) 0.05 MG/ML Prefilled Syringe [SCD] · SARS-CoV-2 (COVID-19) vaccine, mRNA-1283 OMICRON (LP.8.1) 0.2 ML Prefilled Syringe [SY]31These highlights do not include all the information needed to use MNEXSPIKE safely and effectively. See full prescribing information for MNEXSPIKE . MNEXSPIKE (COVID-19 Vaccine, mRNA) injectable suspension, for intramuscular use 2025-2026 Formula Initial U.S. Approval: 202520250827