NDC 53002-2712
Mirtazapine 45 mg tablet, film coated
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Rising Pharma Holdings, Inc.'s NDC 57237-010.
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 |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
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
53002-2712-353002-2712-9- Official label
- DailyMed (National Library of Medicine), updated Jun 7, 2023
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