NDC 73309-231-01 - Mitotane

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 73309-231
Requested NDC: 73309-231-01
Package NDCs from labels: 73309-231-01
Manufacturer: BLUEBAY SHANDONG CO.,LTD
Effective date: 2020-12-30
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Mitotane - BLUEBAY SHANDONG CO.,LTD	BLUEBAY SHANDONG CO.,LTD	2020-12-30	BULK INGREDIENT

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

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	Exact identifier unii: 78E4J5IB5J
Lysodren	MITOTANE	HRA Pharma Rare Diseases	f0cd76e9-460c-450e-b094-172e636f340a	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 78E4J5IB5J

Reported adverse events (FAERS/openFDA)#

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