LYSODREN
- Product NDC
- 0015-3080
- 11-digit product format
- 000153080
- Labeler code
- 0015
- Product ID
- 0015-3080_bacf9c5c-6119-4219-8d8d-f3c2db33e18e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MITOTANE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- E.R. Squibb & Sons, L.L.C.
- Application
- NDA016885
- Marketing category
- NDA
- Marketing start
- 2009-06-01
- Marketing end
- 2021-03-31
- Substance
- MITOTANE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cytochrome P450 3A4 Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0015-3080-60 | 00015308060 | 100 TABLET in 1 BOTTLE (0015-3080-60) | 100 tablet | 2009-06-01 | 2021-03-31 | No | No | Current |