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Last Updated: December 12, 2025

List of Excipients in API MITOTANE

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Excipients in NDA-approved (novel) drugs containing MITOTANE

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
ER Squibb & Sons LLC	LYSODREN	mitotane	0015-3080	CELLULOSE, MICROCRYSTALLINE
ER Squibb & Sons LLC	LYSODREN	mitotane	0015-3080	POLYETHYLENE GLYCOL 3350
ER Squibb & Sons LLC	LYSODREN	mitotane	0015-3080	SILICON DIOXIDE
ESTEVE PHARMACEUTICALS SA	LYSODREN	mitotane	68118-080	CELLULOSE, MICROCRYSTALLINE
ESTEVE PHARMACEUTICALS SA	LYSODREN	mitotane	68118-080	POLYETHYLENE GLYCOL 3350
ESTEVE PHARMACEUTICALS SA	LYSODREN	mitotane	68118-080	SILICON DIOXIDE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Detailed excipient profiles for MITOTANE

Excipient focus: CELLULOSE, MICROCRYSTALLINE

MITOTANE drug variants containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
ER Squibb & Sons LLC	mitotane	0015-3080
ESTEVE PHARMACEUTICALS SA	mitotane	68118-080
HRA Pharma Rare Diseases	mitotane	76336-080
>Company	>Ingredient	>NDC

MITOTANE drug variants not containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 3350

MITOTANE drug variants containing POLYETHYLENE GLYCOL 3350

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Company	Ingredient	NDC
ER Squibb & Sons LLC	mitotane	0015-3080
ESTEVE PHARMACEUTICALS SA	mitotane	68118-080
HRA Pharma Rare Diseases	mitotane	76336-080
>Company	>Ingredient	>NDC

MITOTANE drug variants not containing POLYETHYLENE GLYCOL 3350

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE

MITOTANE drug variants containing SILICON DIOXIDE

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Company	Ingredient	NDC
ER Squibb & Sons LLC	mitotane	0015-3080
ESTEVE PHARMACEUTICALS SA	mitotane	68118-080
HRA Pharma Rare Diseases	mitotane	76336-080
>Company	>Ingredient	>NDC

MITOTANE drug variants not containing SILICON DIOXIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: STARCH, CORN

MITOTANE drug variants containing STARCH, CORN

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Company	Ingredient	NDC
ESTEVE PHARMACEUTICALS SA	mitotane	68118-080
HRA Pharma Rare Diseases	mitotane	76336-080
>Company	>Ingredient	>NDC

MITOTANE drug variants not containing STARCH, CORN

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Company	Ingredient	NDC
ER Squibb & Sons LLC	mitotane	0015-3080
>Company	>Ingredient	>NDC

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