NDC 21695-083
Mirtazapine 45 mg tablet, film coated
On the label: Rebel Distributors Corp... It's repackaged: Rebel Distributors Corp.. rebottles it from Aurobindo Pharma Limited's NDC 65862-032.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Apl Healthcare Limited | Tirupati, India | Makes it and tests it | Problems found, fixed voluntarilyDec 17, 2025 · 5 inspections |
| Aurobindo Pharma Limited | Medchal, India | Makes it and tests it | Problems found, fixed voluntarilyJul 21, 2023 · 13 inspections, 1 with FDA action |
Product details
- Generic drug
- Mirtazapine: every company that makes it
- Form
- tablet, film coated
- Strength
- 45 mg
- Approval
- ANDA ANDA076921
- On the market since
- Oct 22, 2004
- Package NDCs
21695-083-30- Official label
- DailyMed (National Library of Medicine), updated Oct 6, 2010
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