FDA.reportPublic FDA data

idursulfase 6 MG in 3 ML Injection

RxCUI
644104
RxNorm name
idursulfase 6 MG in 3 ML Injection
Display name
idursulfase 6 MG in 3 ML Injection
Full name
idursulfase 6 MG in 3 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:00

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125151Elapraseidursulfase351(a)Rx2026-07-01

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
ELAPRASEIDURSULFASETakeda Pharmaceuticals America, Inc.60cba843-5aab-4dd7-96dc-66648d413be32025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 644104

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
60cba843-5aab-4dd7-96dc-66648d413be3idursulfase 6 MG in 3 ML Injection [PSN] · 3 ML idursulfase 2 MG/ML Injection [SCD] · idursulfase 6 MG per 3 ML Injection [SY]325These highlights do not include all the information needed to use ELAPRASE safely and effectively. See full prescribing information for ELAPRASE. ELAPRASE ® (idursulfase) injection, for intravenous use Initial U.S. Approval: 200620250415