NDC 72189-223
Montelukast Sodium 5 mg tablet, chewable
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-728.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hetero Labs Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyAug 12, 2022 · 5 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- tablet, chewable, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA204093
- On the market since
- May 21, 2021
- Package NDCs
72189-223-30- Official label
- DailyMed (National Library of Medicine), updated Jan 20, 2025
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