FDA.reportPublic FDA data

PEMGARDA 500 MG in 4 ML Injection (EUA)

RxCUI
2677811
RxNorm name
PEMGARDA 500 MG in 4 ML Injection (EUA)
Display name
PEMGARDA 500 MG in 4 ML Injection (EUA)
Full name
PEMGARDA 500 MG in 4 ML Injection (EUA)
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pemgardaPEMIVIBARTInvivyd, Inc0bdc20a9-791f-9a06-e063-6394a90a84cc2025-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2677811

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
0bdc20a9-791f-9a06-e063-6394a90a84ccPEMGARDA 500 MG in 4 ML Injection (EUA) [PSN] · 4 ML pemivibart 125 MG/ML Injection [Pemgarda] [SBD] · Pemgarda 500 MG per 4 ML Injection (EUA) [SY]310FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION OF PEMGARDA (PEMIVIBART): These highlights do not include all the information needed to use see full prescribing information for and Initial U.S. Approval20250912