FDA.reportPublic FDA data

SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-BNT162b2 OMICRON (LP.8.1) 0.3 ML Prefilled Syringe, 12y+

RxCUI
2722598
RxNorm name
SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-BNT162b2 OMICRON (LP.8.1) 0.3 ML Prefilled Syringe, 12y+
Display name
SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-BNT162b2 OMICRON (LP.8.1) 0.3 ML Prefilled Syringe, 12y+
Full name
SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-BNT162b2 OMICRON (LP.8.1) 0.3 ML Prefilled Syringe, 12y+
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:56

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125742ComirnatyCOVID-19 Vaccine, mRNA351(a)Disc2026-06-01

RxNav Current And Historical NDCs#

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UNII Substances#

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DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
48c86164-de07-4041-b9dc-f2b5744714e5SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-BNT162b2 OMICRON (LP.8.1) 0.3 ML Prefilled Syringe, 12y+SY20These highlights do not include all the information needed to use COMIRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY ® (COVID-19 Vaccine, mRNA) injectable suspension, for intramuscular use 2025-2026 Formula Initial U.S. Approval: 202120260303
48c86164-de07-4041-b9dc-f2b5744714e5SARS-CoV-2 (COVID-19) vaccine 2025-2026, mRNA-BNT162b2 OMICRON (LP.8.1) 0.3 ML Prefilled Syringe, 12y+PSN20These highlights do not include all the information needed to use COMIRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY ® (COVID-19 Vaccine, mRNA) injectable suspension, for intramuscular use 2025-2026 Formula Initial U.S. Approval: 202120260303
48c86164-de07-4041-b9dc-f2b5744714e50.3 ML SARS-CoV-2 (COVID-19) vaccine, mRNA-BNT162b2 OMICRON (LP.8.1) 0.1 MG/ML Prefilled SyringeSCD20These highlights do not include all the information needed to use COMIRNATY safely and effectively. See full prescribing information for COMIRNATY. COMIRNATY ® (COVID-19 Vaccine, mRNA) injectable suspension, for intramuscular use 2025-2026 Formula Initial U.S. Approval: 202120260303