FDA.reportPublic FDA data

VYVGART Hytrulo 1,000 MG / 10,000 UNT in 5 ML Prefilled Syringe

RxCUI
2712088
RxNorm name
VYVGART Hytrulo 1,000 MG / 10,000 UNT in 5 ML Prefilled Syringe
Display name
VYVGART Hytrulo 1,000 MG / 10,000 UNT in 5 ML Prefilled Syringe
Full name
VYVGART Hytrulo 1,000 MG / 10,000 UNT in 5 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761304Vyvgart Hytruloefgartigimod alfa and hyaluronidase-qvfc351(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
VYVGART HytruloEFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT)argenx US7104d9e5-9910-47f5-9a93-741ac50f43b62026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 2712088

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
7104d9e5-9910-47f5-9a93-741ac50f43b6VYVGART Hytrulo 1,000 MG / 10,000 UNT in 5 ML Prefilled Syringe [PSN] · 5 ML efgartigimod alfa-qvfc 200 MG/ML / hyaluronidase-qvfc 2000 UNT/ML Prefilled Syringe [Vyvgart Hytrulo] [SBD] · Vyvgart Hytrulo (efgartigimod alfa-hyaluronidase-qvfc 1,000 MG / 10,000 UNT) per 5 ML Prefilled Syringe [SY]312These highlights do not include all the information needed to use VYVGART HYTRULO safely and effectively. See full prescribing information for VYVGART HYTRULO. VYVGART HYTRULO ® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use Initial U.S. Approval: 202320260513