# MITOTANE (MITOTANE) by KEKULE PHARMA LIMITED: new bulk ingredient listing

**Launch Signal Score:** 15/100

| Field | Value |
|---|---|
| Generic name | MITOTANE |
| NDC | 53220-124 |
| Labeler | KEKULE PHARMA LIMITED |
| Product type | BULK INGREDIENT |
| Approval pathway | BULK INGREDIENT |
| Dosage form | POWDER |
| Active ingredients | MITOTANE 1 kg/kg |
| Marketing start | 2026-10-26 |
| Package configurations | 1 |

## Why this score


Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=53220-124). Last refreshed: 2026-11-04T18:12:05.743Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.