FDA.reportPublic FDA data

Galafold 123 MG (as migalastat HCl 150 MG) Oral Capsule

RxCUI
2054263
RxNorm name
Galafold 123 MG (as migalastat HCl 150 MG) Oral Capsule
Display name
Galafold 123 MG (as migalastat HCl 150 MG) Oral Capsule
Full name
Galafold 123 MG (as migalastat HCl 150 MG) Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

RxNav Current And Historical NDCs#

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UNII Substances#

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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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GalafoldMIGALASTAT HYDROCHLORIDEAmicus Therapeutics US, LLC66dbd928-0f1c-48b1-a832-54e4abd9f1db2025-08-28Adverse reactionsExact identifier
rxcui: 2054263

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
66dbd928-0f1c-48b1-a832-54e4abd9f1dbGalafold 123 MG Oral Capsule [PSN] · migalastat 123 MG Oral Capsule [Galafold] [SBD] · Galafold 123 MG (as migalastat HCl 150 MG) Oral Capsule [SY] · Galafold 123 MG Oral Capsule [SY]418These highlights do not include all the information needed to use GALAFOLD safely and effectively. See full prescribing information for GALAFOLD. GALAFOLD ® (migalastat) capsules, for oral use Initial U.S. Approval: 201820250828