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)Rx2026-06-01

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#

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#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
0caa2565-12b2-0ad0-1f9a-273e81c3d4cc5 ML elosulfase alfa 1 MG/ML Injection [Vimizim]SBD38These 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
0caa2565-12b2-0ad0-1f9a-273e81c3d4ccVimizim 5 MG per 5 ML InjectionSY38These 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
0caa2565-12b2-0ad0-1f9a-273e81c3d4cc5 ML Vimizim 1 MG/ML InjectionSY38These 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
0caa2565-12b2-0ad0-1f9a-273e81c3d4ccVimizim 5 MG in 5 ML InjectionPSN38These 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