FDA.reportPublic FDA data

cysteamine 25 MG Delayed Release Oral Capsule

RxCUI
1421467
RxNorm name
cysteamine 25 MG Delayed Release Oral Capsule
Display name
cysteamine 25 MG Delayed Release Oral Capsule
Full name
cysteamine 25 MG Delayed Release Oral Capsule
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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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
PROCYSBICYSTEAMINE BITARTRATEHorizon Therapeutics USA, Inc.d3a3ec28-f746-463a-bb92-3bc8826db09e2026-06-25Warnings, Adverse reactionsExact identifier
rxcui: 1421467

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
d3a3ec28-f746-463a-bb92-3bc8826db09ecysteamine 25 MG Delayed Release Oral Capsule [PSN] · cysteamine 25 MG Delayed Release Oral Capsule [SCD] · cysteamine 25 MG (as cysteamine bitartrate 74 mg) Delayed Release Oral Capsule [SY]312These highlights do not include all the information needed to use PROCYSBI safely and effectively. See Full Prescribing Information for PROCYSBI. PROCYSBI ® (cysteamine bitartrate) delayed-release capsules, for oral use PROCYSBI ® (cysteamine bitartrate) delayed-release oral granules Initial U.S. Approval: 199420250409