FDA.reportPublic FDA data

galsulfase 5 MG in 5 ML Injection

RxCUI
578037
RxNorm name
galsulfase 5 MG in 5 ML Injection
Display name
galsulfase 5 MG in 5 ML Injection
Full name
galsulfase 5 MG in 5 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:59

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125117Naglazymegalsulfase351(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
NAGLAZYMEGALSULFASEBioMarin Pharmaceutical Inc.59341250-deac-ed71-3823-a4f5d64dbd772024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 578037

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
59341250-deac-ed71-3823-a4f5d64dbd77galsulfase 5 MG in 5 ML Injection [PSN] · 5 ML galsulfase 1 MG/ML Injection [SCD] · galsulfase 5 MG per 5 ML Injection [SY]339These highlights do not include all the information needed to use NAGLAZYME® safely and effectively. See full prescribing information for NAGLAZYME. NAGLAZYME (galsulfase) injection, for intravenous use Initial U.S. Approval: 200520240918