mitotane 500 MG Oral Tablet

RxCUI: 197988
RxNorm name: mitotane 500 MG Oral Tablet
Display name: mitotane 500 MG Oral Tablet
Full name: mitotane 500 MG Oral Tablet
Term type: SCD
Status: DailyMed mapping
Updated: 2026-06-04 23:38:55

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.

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Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lysodren	MITOTANE	HRA Pharma Rare Diseases	f0cd76e9-460c-450e-b094-172e636f340a	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 197988

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
4046a224-8832-daa2-e063-6294a90a11d7	mitotane 500 MG Oral Tablet [PSN] · mitotane 500 MG Oral Tablet [SCD]	2	17	These highlights do not include all the information needed to use LYSODREN safely and effectively. See full prescribing information for LYSODREN. LYSODREN ® (mitotane) tablets, for oral use Initial U.S. Approval: 1970	20260521
f0cd76e9-460c-450e-b094-172e636f340a	mitotane 500 MG Oral Tablet [PSN] · mitotane 500 MG Oral Tablet [SCD]	2	15	These highlights do not include all the information needed to use LYSODREN safely and effectively. See full prescribing information for LYSODREN. LYSODREN ® (mitotane) tablets, for oral use Initial U.S. Approval: 1970	20251008