FDA.reportPublic FDA data

laronidase 2.9 MG in 5 ML Injection

RxCUI
403822
RxNorm name
laronidase 2.9 MG in 5 ML Injection
Display name
laronidase 2.9 MG in 5 ML Injection
Full name
laronidase 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)Rx2026-07-01

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
ALDURAZYMELARONIDASEGenzyme Corporationa80ac249-cae4-41f3-88bb-344088b20e602026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 403822

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-344088b20e60laronidase 2.9 MG in 5 ML Injection [PSN] · 5 ML laronidase 0.58 MG/ML Injection [SCD] · laronidase 2.9 MG per 5 ML Injection [SY]337These 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