NDC 16729-115
Mitomycin 5 mg per 10 mL injection, powder, lyophilized, for solution
On the label: Accord Healthcare Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Product details
- Generic drug
- Mitomycin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 5 mg per 10 mL
- Approval
- ANDA ANDA064144
- On the market since
- Jun 18, 2009
- Package NDCs
16729-115-05- Official label
- DailyMed (National Library of Medicine), updated Apr 22, 2025
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