NDC 53217-357
Montelukast Sodium 5 mg tablet, chewable
On the label: Aidarex Pharmaceuticals LLC. It's repackaged: Aidarex Pharmaceuticals LLC rebottles it from Ajanta Pharma USA Inc.'s NDC 27241-017.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ajanta Pharma Limited | Chhatrapati Sambhajinagar, India | Makes it | Problems found, fixed voluntarilyApr 21, 2026 · 6 inspections |
Repackaging site
- Aidarex Pharmaceuticals, Location not on file · repackages it
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- tablet, chewable
- Strength
- 5 mg
- Approval
- ANDA ANDA203328
- On the market since
- Dec 26, 2017
- Package NDCs
53217-357-30- Official label
- DailyMed (National Library of Medicine), updated Aug 16, 2018
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