pitolisant 17.8 MG (as pitolisant HCl 20 MG) Oral Tablet

RxCUI
2197892
RxNorm name
pitolisant 17.8 MG (as pitolisant HCl 20 MG) Oral Tablet
Display name
pitolisant 17.8 MG (as pitolisant HCl 20 MG) Oral Tablet
Full name
pitolisant 17.8 MG (as pitolisant HCl 20 MG) Oral Tablet
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

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.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLC8daa5562-824e-476c-9652-26ceef3d4b0e2026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 2197892

Reported adverse events (FAERS/openFDA)#

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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
8daa5562-824e-476c-9652-26ceef3d4b0epitolisant 17.8 MG Oral Tablet [PSN] · pitolisant 17.8 MG Oral Tablet [SCD] · pitolisant 17.8 MG (as pitolisant HCl 20 MG) Oral Tablet [SY]318These highlights do not include all the information needed to use WAKIX ® safely and effectively. See full prescribing information for WAKIX. WAKIX ® (pitolisant) tablets, for oral use Initial U.S. Approval: 201920260213