NDC 68727-800
Defitelio 80 mg per 1 mL injection, solution
On the label: Jazz Pharmaceuticals, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Gentium S.r.L | Villa Guardia, Italy | Makes the active ingredient and tests it | Problems found, fixed voluntarilyDec 17, 2021 · 3 inspections |
| Jazz Pharmaceuticals Ireland Limited | Dublin 4, Ireland | Makes it | Not inspected on record |
| Patheon Italia S.p.A | Ferentino, Italy | Makes it | Problems found, fixed voluntarilyFeb 25, 2022 · 7 inspections, 1 with FDA action |
Product details
- Generic drug
- Defibrotide Free Acid: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 80 mg per 1 mL
- Approval
- NDA NDA208114
- On the market since
- Mar 30, 2016
- Package NDCs
68727-800-0168727-800-02- Official label
- DailyMed (National Library of Medicine), updated Jul 1, 2025
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