FDA.reportPublic FDA data

5 ML elosulfase alfa 1 MG/ML Injection [Vimizim]

RxCUI
1490052
RxNorm name
5 ML elosulfase alfa 1 MG/ML Injection [Vimizim]
Display name
5 ML elosulfase alfa 1 MG/ML Injection [Vimizim]
Full name
5 ML elosulfase alfa 1 MG/ML Injection [Vimizim]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125460Vimizimelosulfase alfa351(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
VIMIZIMELOSULFASE ALFABioMarin Pharmaceutical Inc.0caa2565-12b2-0ad0-1f9a-273e81c3d4cc2025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1490052

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
0caa2565-12b2-0ad0-1f9a-273e81c3d4ccVimizim 5 MG in 5 ML Injection [PSN] · 5 ML elosulfase alfa 1 MG/ML Injection [Vimizim] [SBD] · 5 ML Vimizim 1 MG/ML Injection [SY] · Vimizim 5 MG per 5 ML Injection [SY]438These highlights do not include all the information needed to use VIMIZIM safely and effectively. See full prescribing information for VIMIZIM. VIMIZIM (elosulfase alfa) injection, for intravenous use Initial U.S. Approval: 201420251030