FDA.reportPublic FDA data

PROCYSBI 75 MG Delayed Release Oral Granules

RxCUI
2284516
RxNorm name
PROCYSBI 75 MG Delayed Release Oral Granules
Display name
PROCYSBI 75 MG Delayed Release Oral Granules
Full name
PROCYSBI 75 MG Delayed Release Oral Granules
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

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: 2284516

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-bb92-3bc8826db09ePROCYSBI 75 MG Delayed Release Oral Granules [PSN] · cysteamine 75 MG Delayed Release Oral Granules [Procysbi] [SBD] · Procysbi 75 MG Delayed Release Oral Granules [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