NDC 63323-762
Topotecan Hydrochloride 4 mg per 4 mL injection, powder, lyophilized, for solution
On the label: Fresenius Kabi, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Grand Island, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyOct 13, 2023 · 14 inspections, 2 with FDA action |
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
| ScinoPharm Taiwan, Ltd. | Tainan, Taiwan | Makes the active ingredient | Serious problems, FDA actionJun 23, 2026 · 7 inspections, 1 with FDA action |
Product details
- Generic drug
- Topotecan: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 4 mg per 4 mL
- Approval
- ANDA ANDA091089
- On the market since
- Nov 30, 2010
- Package NDCs
63323-762-10- Official label
- DailyMed (National Library of Medicine), updated Jan 14, 2026
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