FDA.reportPublic FDA data

Arexvy 120 MCG per 0.5 ML Injection

RxCUI
2636599
RxNorm name
Arexvy 120 MCG per 0.5 ML Injection
Display name
Arexvy 120 MCG per 0.5 ML Injection
Full name
Arexvy 120 MCG per 0.5 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:49

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125775ArexvyRespiratory Syncytial Virus Vaccine, Adjuvanted351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
1e50f275-002e-413f-a840-66ee3cb3740cAREXVY 120 MCG in 0.5 ML Injection [PSN] · 0.5 ML respiratory syncytial virus pre-fusion F protein, recombinant 0.24 MG/ML Injection [Arexvy] [SBD] · 0.5 ML Arexvy 0.24 MG/ML Injection [SY] · Arexvy 120 MCG per 0.5 ML Injection [SY]410These highlights do not include all the information needed to use AREXVY safely and effectively. See full prescribing information for AREXVY. AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) for injectable suspension, for intramuscular use Initial U.S. Approval: 202320260430