FDA.reportPublic FDA data

0.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection

RxCUI
2642142
RxNorm name
0.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection
Display name
0.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection
Full name
0.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:19

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125769AbrysvoRespiratory Syncytial Virus Vaccine351(a)Rx2026-09-01

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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
be18292e-b1a2-4815-a0ed-003efaa6bea3respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 60 MCG / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 60 MCG in 0.5 ML Injection [PSN] · 0.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection [SCD] · respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 60 MCG / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 60 MCG per 0.5 ML Injection [SY]314These highlights do not include all the information needed to use ABRYSVO safely and effectively. See full prescribing information for ABRYSVO. ABRYSVO ® (Respiratory Syncytial Virus Vaccine) for injection, for intramuscular use Initial U.S. Approval: 202320251223