FDA.reportPublic FDA data

ALDURAZYME 2.9 MG in 5 ML Injection

RxCUI
404492
RxNorm name
ALDURAZYME 2.9 MG in 5 ML Injection
Display name
ALDURAZYME 2.9 MG in 5 ML Injection
Full name
ALDURAZYME 2.9 MG in 5 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:14

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125058Aldurazymelaronidase351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

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
a80ac249-cae4-41f3-88bb-344088b20e60ALDURAZYME 2.9 MG in 5 ML Injection [PSN] · 5 ML laronidase 0.58 MG/ML Injection [Aldurazyme] [SBD] · 5 ML Aldurazyme 0.58 MG/ML Injection [SY] · Aldurazyme 2.9 MG per 5 ML Injection [SY]437These highlights do not include all the information needed to use ALDURAZYME safely and effectively. See full prescribing information for ALDURAZYME. ALDURAZYME (laronidase) injection, for intravenous use Initial U.S. Approval: 200320231222