NDC 68727-712
Zepzelca .5 mg per 1 mL injection, powder, lyophilized, for solution
On the label: Jazz Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| GP Pharm S.a.u. | Sant Quinti De Mediona, Spain | Makes it | Problems found, fixed voluntarilySep 21, 2023 · 3 inspections |
| Jazz Pharmaceuticals Ireland Limited | Dublin 4, Ireland | Makes it | Not inspected on record |
| 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, tests it, packages it and labels it | Serious problems, FDA actionSep 26, 2025 · 11 inspections, 1 with FDA action |
| AndersonBrecon Inc. | Rockford, IL, United States | Packages it and labels it | No problems foundMay 8, 2025 · 6 inspections |
Product details
- Generic drug
- Lurbinectedin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- .5 mg per 1 mL
- Approval
- NDA NDA213702
- On the market since
- Jun 15, 2020
- Package NDCs
68727-712-01- Official label
- DailyMed (National Library of Medicine), updated Sep 30, 2026
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