NDC 59676-610
Yondelis 0.05 mg per 1 mL injection, powder, lyophilized, for solution
On the label: Janssen Products LP.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pharma Mar S.A. | Colmenar Viejo, Spain | Makes the active ingredient | Problems found, fixed voluntarilyJan 26, 2023 · 4 inspections |
| Simtra Deutschland GmbH | Halle/Westfalen, Germany | Makes it | Serious problems, FDA actionSep 26, 2025 · 11 inspections, 1 with FDA action |
| Janssen Pharmaceutica NV | Beerse, Belgium | Packages it and labels it | Problems found, fixed voluntarilySep 5, 2025 · 8 inspections |
Product details
- Generic drug
- Trabectedin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 0.05 mg per 1 mL
- Approval
- NDA NDA207953
- On the market since
- Oct 23, 2015
- Package NDCs
59676-610-01- Official label
- DailyMed (National Library of Medicine), updated Jan 6, 2026
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