Home NDC 76336-080 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 44 .
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 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 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…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N016885-001 LYSODREN 500MG TABLET / ORAL RLD, RS, Approved before 1982 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
DailyMed Product Concepts# 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 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.
DailyMed RxNorm Mappings# 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