FDA.reportPublic FDA data

efgartigimod alfa-fcab 400 MG in 20 ML Injection

RxCUI
2587723
RxNorm name
efgartigimod alfa-fcab 400 MG in 20 ML Injection
Display name
efgartigimod alfa-fcab 400 MG in 20 ML Injection
Full name
efgartigimod alfa-fcab 400 MG in 20 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761195Vyvgartefgartigimod alfa-fcab351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VYVGARTEFGARTIGIMOD ALFAargenx US8aefc8e3-26d6-4ff6-aab9-a7542927e0842026-05-13Warnings, Adverse reactionsExact identifier
rxcui: 2587723

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
8aefc8e3-26d6-4ff6-aab9-a7542927e084efgartigimod alfa-fcab 400 MG in 20 ML Injection [PSN] · 20 ML efgartigimod alfa-fcab 20 MG/ML Injection [SCD] · efgartigimod alfa-fcab 20 MG/ML per 20 ML Injection [SY] · efgartigimod alfa-fcab 400 MG per 20 ML Injection [SY]415These highlights do not include all the information needed to use VYVGART safely and effectively. See full prescribing information for VYVGART. VYVGART ® (efgartigimod alfa-fcab) injection, for intravenous use Initial U.S. Approval: 202120260513