NDC 58458-002
Azacitidine 100 mg injection, powder, lyophilized, for solution
On the label: Reliance Life Sciences Private Limited.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Reliance Life Sciences Private Limited | Navi Mumbai, India | Makes it, makes the active ingredient, tests it, packages it and labels it | Serious problems, FDA actionFeb 27, 2026 · 8 inspections, 2 with FDA action |
Product details
- Generic drug
- Azacitidine: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous; subcutaneous
- Strength
- 100 mg
- Approval
- ANDA ANDA217453
- On the market since
- Jul 30, 2025
- Package NDCs
58458-002-02- Official label
- DailyMed (National Library of Medicine), updated May 29, 2025
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