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Last Updated: December 17, 2025

List of Excipients in API PITOLISANT HYDROCHLORIDE

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Excipients in NDA-approved (novel) drugs containing PITOLISANT HYDROCHLORIDE

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Harmony Biosciences LLC	WAKIX	pitolisant hydrochloride	72028-045	CELLULOSE, MICROCRYSTALLINE	2031-06-21
Harmony Biosciences LLC	WAKIX	pitolisant hydrochloride	72028-045	CROSPOVIDONE	2031-06-21
Harmony Biosciences LLC	WAKIX	pitolisant hydrochloride	72028-045	MAGNESIUM STEARATE	2031-06-21
Harmony Biosciences LLC	WAKIX	pitolisant hydrochloride	72028-045	POLYETHYLENE GLYCOL	2031-06-21
Harmony Biosciences LLC	WAKIX	pitolisant hydrochloride	72028-045	POLYVINYL ALCOHOL	2031-06-21
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Detailed excipient profiles for PITOLISANT HYDROCHLORIDE

Excipient focus: CELLULOSE, MICROCRYSTALLINE

PITOLISANT HYDROCHLORIDE drug variants containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
Harmony Biosciences LLC	pitolisant hydrochloride	72028-045
>Company	>Ingredient	>NDC

PITOLISANT HYDROCHLORIDE drug variants not containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: CROSPOVIDONE

PITOLISANT HYDROCHLORIDE drug variants containing CROSPOVIDONE

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Company	Ingredient	NDC
Harmony Biosciences LLC	pitolisant hydrochloride	72028-045
>Company	>Ingredient	>NDC

PITOLISANT HYDROCHLORIDE drug variants not containing CROSPOVIDONE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: MAGNESIUM STEARATE

PITOLISANT HYDROCHLORIDE drug variants containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Harmony Biosciences LLC	pitolisant hydrochloride	72028-045
>Company	>Ingredient	>NDC

PITOLISANT HYDROCHLORIDE drug variants not containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL

PITOLISANT HYDROCHLORIDE drug variants containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
Harmony Biosciences LLC	pitolisant hydrochloride	72028-045
>Company	>Ingredient	>NDC

PITOLISANT HYDROCHLORIDE drug variants not containing POLYETHYLENE GLYCOL

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: POLYVINYL ALCOHOL

PITOLISANT HYDROCHLORIDE drug variants containing POLYVINYL ALCOHOL

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Company	Ingredient	NDC
Harmony Biosciences LLC	pitolisant hydrochloride	72028-045
>Company	>Ingredient	>NDC

PITOLISANT HYDROCHLORIDE drug variants not containing POLYVINYL ALCOHOL

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE

PITOLISANT HYDROCHLORIDE drug variants containing SILICON DIOXIDE

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Company	Ingredient	NDC
Harmony Biosciences LLC	pitolisant hydrochloride	72028-045
>Company	>Ingredient	>NDC

PITOLISANT HYDROCHLORIDE drug variants not containing SILICON DIOXIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: TALC

PITOLISANT HYDROCHLORIDE drug variants containing TALC

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Company	Ingredient	NDC
Harmony Biosciences LLC	pitolisant hydrochloride	72028-045
>Company	>Ingredient	>NDC

PITOLISANT HYDROCHLORIDE drug variants not containing TALC

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

PITOLISANT HYDROCHLORIDE drug variants containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Harmony Biosciences LLC	pitolisant hydrochloride	72028-045
>Company	>Ingredient	>NDC

PITOLISANT HYDROCHLORIDE drug variants not containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

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