Mitotane

Manufacturer: BLUEBAY SHANDONG CO.,LTD
Effective date: 2020-12-30
Label type: BULK INGREDIENT
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:49:49

Label at a glance#

ProductMitotane

Active ingredientMITOTANE

Label structure1 sections

Label contents#

Full prescribing information#

Mitotane

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
abe167df-4819-3241-373e-2719d5c257e6	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73309-231-01	Mitotane	1 kg in 1 PACKAGE	POWDER	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73309-231	MITOTANE POWDER [BLUEBAY SHANDONG CO.,LTD]	1	1 package rows	20201231_100cd76d-6b6b-4324-b171-af012bd6f653.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Mitotane

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73309-231	73309-231-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MITOTANE	78E4J5IB5J	ACTIB

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lysodren	MITOTANE	ESTEVE PHARMACEUTICALS, S.A.	4046a224-8832-daa2-e063-6294a90a11d7	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOTANE
Lysodren	MITOTANE	HRA Pharma Rare Diseases	f0cd76e9-460c-450e-b094-172e636f340a	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MITOTANE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.