FDA.reportPublic FDA data

respiratory syncytial virus pre-fusion F protein, recombinant 120 MCG per 0.5 ML Injection

RxCUI
2636593
RxNorm name
respiratory syncytial virus pre-fusion F protein, recombinant 120 MCG per 0.5 ML Injection
Display name
respiratory syncytial virus pre-fusion F protein, recombinant 120 MCG per 0.5 ML Injection
Full name
respiratory syncytial virus pre-fusion F protein, recombinant 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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UNII Substances#

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Reported adverse events (FAERS/openFDA)#

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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
1e50f275-002e-413f-a840-66ee3cb3740crespiratory syncytial virus pre-fusion F protein, recombinant 120 MCG in 0.5 ML Injection [PSN] · 0.5 ML respiratory syncytial virus pre-fusion F protein, recombinant 0.24 MG/ML Injection [SCD] · respiratory syncytial virus pre-fusion F protein, recombinant 120 MCG per 0.5 ML Injection [SY]310These 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