FDA.reportPublic FDA data

5 ML Naglazyme 1 MG/ML Injection

RxCUI
584222
RxNorm name
5 ML Naglazyme 1 MG/ML Injection
Display name
5 ML Naglazyme 1 MG/ML Injection
Full name
5 ML Naglazyme 1 MG/ML Injection
Term type
SY
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: 584222

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-a4f5d64dbd77Naglazyme 5 MG in 5 ML Injection [PSN] · 5 ML galsulfase 1 MG/ML Injection [Naglazyme] [SBD] · 5 ML Naglazyme 1 MG/ML Injection [SY] · Naglazyme 5 MG per 5 ML Injection [SY]439These 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