Lysodren
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
Approved
Approval ID
f0cd76e9-460c-450e-b094-172e636f340a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2024
Manufacturers
FDA
HRA Pharma Rare Diseases
DUNS: 571682231
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mitotane
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76336-080
Application NumberNDA016885
Product Classification
M
Marketing Category
C73594
G
Generic Name
mitotane
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2024
FDA Product Classification
INGREDIENTS (8)
mitotaneActive
Quantity: 500 mg in 1 1
Code: 78E4J5IB5J
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MITOTANEActive
Quantity: 500 mg in 1 1
Code: 78E4J5IB5J
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT