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)Rx2026-06-01

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
VYVGART HytruloEFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT)argenx US7104d9e5-9910-47f5-9a93-741ac50f43b62026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 2712088

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
7104d9e5-9910-47f5-9a93-741ac50f43b6VYVGART Hytrulo 1,000 MG / 10,000 UNT in 5 ML Prefilled SyringePSN12These 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
7104d9e5-9910-47f5-9a93-741ac50f43b65 ML efgartigimod alfa-qvfc 200 MG/ML / hyaluronidase-qvfc 2000 UNT/ML Prefilled Syringe [Vyvgart Hytrulo]SBD12These 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
7104d9e5-9910-47f5-9a93-741ac50f43b6Vyvgart Hytrulo (efgartigimod alfa-hyaluronidase-qvfc 1,000 MG / 10,000 UNT) per 5 ML Prefilled SyringeSY12These 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