pitolisant 4.45 MG Oral Tablet

RxCUI: 2197884
RxNorm name: pitolisant 4.45 MG Oral Tablet
Display name: pitolisant 4.45 MG Oral Tablet
Full name: pitolisant 4.45 MG Oral Tablet
Term type: PSN
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#

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Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Wakix	PITOLISANT HYDROCHLORIDE	Harmony Biosciences, LLC	8daa5562-824e-476c-9652-26ceef3d4b0e	2026-02-13	Warnings, Adverse reactions	Exact identifier rxcui: 2197884

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 ID	RxNorm mappings	Terms	SPL version	Label	Effective
8daa5562-824e-476c-9652-26ceef3d4b0e	pitolisant 4.45 MG Oral Tablet [PSN] · pitolisant 4.45 MG Oral Tablet [SCD] · pitolisant 4.45 MG (as pitolisant HCl 5 MG) Oral Tablet [SY]	3	18	These 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: 2019	20260213