NDC 71610-563
Montelukast 10 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from XLCare Pharmaceuticals, Inc.'s NDC 72865-175.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Evaric Pharmaceuticals Inc | Hauppauge, NY, United States | Makes it | Problems found, fixed voluntarilyMay 16, 2025 · 3 inspections |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA202843
- On the market since
- Feb 11, 2021
- Package NDCs
71610-563-30- Official label
- DailyMed (National Library of Medicine), updated Jun 26, 2021
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