FDA.reportPublic FDA data

5 ML elosulfase alfa 1 MG/ML Injection

RxCUI
1490047
RxNorm name
5 ML elosulfase alfa 1 MG/ML Injection
Display name
5 ML elosulfase alfa 1 MG/ML Injection
Full name
5 ML elosulfase alfa 1 MG/ML Injection
Term type
SCD
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: 1490047

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-273e81c3d4ccelosulfase alfa 5 MG in 5 ML Injection [PSN] · 5 ML elosulfase alfa 1 MG/ML Injection [SCD] · elosulfase alfa 5 MG per 5 ML Injection [SY]338These 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