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)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
8aefc8e3-26d6-4ff6-aab9-a7542927e084efgartigimod alfa-fcab 400 MG in 20 ML InjectionPSN15These 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
8aefc8e3-26d6-4ff6-aab9-a7542927e084efgartigimod alfa-fcab 400 MG per 20 ML InjectionSY15These 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
8aefc8e3-26d6-4ff6-aab9-a7542927e08420 ML efgartigimod alfa-fcab 20 MG/ML InjectionSCD15These 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
8aefc8e3-26d6-4ff6-aab9-a7542927e084efgartigimod alfa-fcab 20 MG/ML per 20 ML InjectionSY15These 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