Lysodren

Product NDC: 76336-080
11-digit product format: 763360080
Labeler code: 76336
Product ID: 76336-080_40a4cc96-c834-c03b-e063-6394a90a01d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mitotane
Dosage form: TABLET
Route: ORAL
Labeler: HRA Pharma Rare Diseases
Application: NDA016885
Marketing category: NDA
Marketing start: 1978-10-15
Substance: MITOTANE
Active strength: 500 mg/1
Pharmacologic classes: Cytochrome P450 3A4 Inducers [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016885-001	LYSODREN	MITOTANE	500MG	TABLET / ORAL		RLD, RS, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016885-001	LYSODREN	500MG	TABLET / ORAL	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lysodren
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MITOTANE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
78E4J5IB5J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197988	Internal RxNorm lookup
207373	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f0cd76e9-460c-450e-b094-172e636f340a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
abe167df-4819-3241-373e-2719d5c257e6	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76336-080-60	Lysodren	100 in 1 BOTTLE	TABLET	100		15
76336-080-60	Lysodren	1 in 1 CARTON	TABLET	1		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76336-080-60	EA - Each	76336-080	8bc33b93-1174-4767-8a3f-b70f772d2d78	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76336-080	LYSODREN (MITOTANE) TABLET [HRA PHARMA RARE DISEASES]	13	Current NDC, Legacy NDC, 2 package rows	20250504_f0cd76e9-460c-450e-b094-172e636f340a.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 application applno (NDA): 016885 application number: NDA016885
Lysodren	MITOTANE	HRA Pharma Rare Diseases	f0cd76e9-460c-450e-b094-172e636f340a	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 016885 application number: NDA016885 ndc (product): 76336-080

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
78E4J5IB5J	MITOTANE	53-19-0	MITOTANE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
207373	LYSODREN 500 MG Oral Tablet	PSN	f0cd76e9-460c-450e-b094-172e636f340a	15
197988	mitotane 500 MG Oral Tablet	PSN	f0cd76e9-460c-450e-b094-172e636f340a	15
207373	mitotane 500 MG Oral Tablet [Lysodren]	SBD	f0cd76e9-460c-450e-b094-172e636f340a	15
197988	mitotane 500 MG Oral Tablet	SCD	f0cd76e9-460c-450e-b094-172e636f340a	15
207373	Lysodren 500 MG Oral Tablet	SY	f0cd76e9-460c-450e-b094-172e636f340a	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76336-080-60	76336008060	1 BOTTLE in 1 CARTON (76336-080-60) / 100 TABLET in 1 BOTTLE	1 bottle	1978-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lysodren	HRA Pharma Rare Diseases \| ISP Chemicals LLC \| Latina Pharma S.p.A.	2025-10-08	HUMAN PRESCRIPTION DRUG LABEL	15