FDA.reportPublic FDA data

vestronidase alfa-vjbk 10 MG in 5 ML Injection

RxCUI
1989823
RxNorm name
vestronidase alfa-vjbk 10 MG in 5 ML Injection
Display name
vestronidase alfa-vjbk 10 MG in 5 ML Injection
Full name
vestronidase alfa-vjbk 10 MG in 5 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761047Mepseviivestronidase alfa-vjbk351(a)Rx2026-08-01

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
MEPSEVIIVESTRONIDASE ALFAUltragenyx Pharmaceutical Inc.925d4e21-fd98-474d-a34d-a0b3558ed7502025-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1989823

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
925d4e21-fd98-474d-a34d-a0b3558ed750vestronidase alfa-vjbk 10 MG in 5 ML Injection [PSN] · 5 ML vestronidase alfa-vjbk 2 MG/ML Injection [SCD] · vestronidase alfa-vjbk 10 MG per 5 ML Injection [SY]317These highlights do not include all the information needed to use MEPSEVII safely and effectively. See full prescribing information for MEPSEVII . MEPSEVII ® ( vestronidase alfa - vjbk ) injection , for intravenous use Initial U.S. Approval: 201720251118