FDA.reportPublic FDA data

paltusotine 20 MG (equivalent to paltusotine hydrochloride 21.6 MG) Oral Tablet

RxCUI
2724403
RxNorm name
paltusotine 20 MG (equivalent to paltusotine hydrochloride 21.6 MG) Oral Tablet
Display name
paltusotine 20 MG (equivalent to paltusotine hydrochloride 21.6 MG) Oral Tablet
Full name
paltusotine 20 MG (equivalent to paltusotine hydrochloride 21.6 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:07

RxNav Current And Historical NDCs#

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UNII Substances#

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openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PALSONIFYPALTUSOTINECrinetics Pharmaceuticals, Inc.8a6d2ce0-a621-4ee7-983c-977cd948ff4d2025-09-16Warnings, Adverse reactionsExact identifier
rxcui: 2724403

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
8a6d2ce0-a621-4ee7-983c-977cd948ff4dpaltusotine 20 MG Oral Tablet, Once Daily [PSN] · paltusotine 20 MG Oral Tablet [SCD] · paltusotine 20 MG (equivalent to paltusotine hydrochloride 21.6 MG) Oral Tablet [SY]33These highlights do not include all the information needed to use PALSONIFY™ safely and effectively. See full prescribing information for PALSONIFY. PALSONIFY (paltusotine) tablets, for oral use Initial U.S. Approval: 202520250916