FDA.reportPublic FDA data

LYSODREN 500 MG Oral Tablet

RxCUI
207373
RxNorm name
LYSODREN 500 MG Oral Tablet
Display name
LYSODREN 500 MG Oral Tablet
Full name
LYSODREN 500 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LysodrenMITOTANEESTEVE PHARMACEUTICALS, S.A.4046a224-8832-daa2-e063-6294a90a11d72026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 207373
LysodrenMITOTANEHRA Pharma Rare Diseasesf0cd76e9-460c-450e-b094-172e636f340a2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 207373

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 IDRxNorm mappingsTermsSPL versionLabelEffective
4046a224-8832-daa2-e063-6294a90a11d7LYSODREN 500 MG Oral Tablet [PSN] · mitotane 500 MG Oral Tablet [Lysodren] [SBD] · Lysodren 500 MG Oral Tablet [SY]317These 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: 197020260521
f0cd76e9-460c-450e-b094-172e636f340aLYSODREN 500 MG Oral Tablet [PSN] · mitotane 500 MG Oral Tablet [Lysodren] [SBD] · Lysodren 500 MG Oral Tablet [SY]315These 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: 197020251008