FDA.reportPublic FDA data

agalsidase beta 5 MG Injection [Fabrazyme]

RxCUI
1804762
RxNorm name
agalsidase beta 5 MG Injection [Fabrazyme]
Display name
agalsidase beta 5 MG Injection [Fabrazyme]
Full name
agalsidase beta 5 MG Injection [Fabrazyme]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:09

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103979Fabrazymeagalsidase beta351(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
FabrazymeAGALSIDASE BETAGenzyme Corporation988513ab-b06f-4dd0-93f7-d2d4531dcce42025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1804762

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
988513ab-b06f-4dd0-93f7-d2d4531dcce4agalsidase beta 5 MG Injection [Fabrazyme]SBD35These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 200320250822
988513ab-b06f-4dd0-93f7-d2d4531dcce4Fabrazyme 5 MG InjectionPSN35These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 200320250822
988513ab-b06f-4dd0-93f7-d2d4531dcce4Fabrazyme 5 MG InjectionSY35These highlights do not include all the information needed to use FABRAZYME ® safely and effectively. See full prescribing information for FABRAZYME ® . FABRAZYME ® (agalsidase beta) for injection, for intravenous use Initial U.S. Approval: 200320250822