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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 78E4J5IB5J |
| Rxcui | 197988, 207373 |
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 |
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 |