| Product NDC: | 0015-3080 |
| Proprietary Name: | LYSODREN |
| Non Proprietary Name: | MITOTANE |
| Active Ingredient(s): | 500 mg/1 & nbsp; MITOTANE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0015-3080 |
| Labeler Name: | E.R. Squibb & Sons, L.L.C. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA016885 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090601 |
| Package NDC: | 0015-3080-60 |
| Package Description: | 100 TABLET in 1 BOTTLE (0015-3080-60) |
| NDC Code | 0015-3080-60 |
| Proprietary Name | LYSODREN |
| Package Description | 100 TABLET in 1 BOTTLE (0015-3080-60) |
| Product NDC | 0015-3080 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | MITOTANE |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20090601 |
| Marketing Category Name | NDA |
| Labeler Name | E.R. Squibb & Sons, L.L.C. |
| Substance Name | MITOTANE |
| Strength Number | 500 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |