NDC 61919-097
Montelukast Sodium 5 mg tablet, chewable
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Torrent Pharma, Inc.'s NDC 13668-080.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Torrent Pharmaceuticals Limited | Indrad, India | Makes it, makes the active ingredient, tests it and packages it | Problems found, fixed voluntarilyJun 12, 2024 · 7 inspections, 2 with FDA action |
| Torrent Pharmaceuticals Limited | Bharuch, India | Makes it, makes the active ingredient, tests it and packages it | No problems foundJan 23, 2026 · 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
- Strength
- 5 mg
- Approval
- ANDA ANDA090984
- On the market since
- Mar 29, 2017
- Package NDCs
61919-097-30- Official label
- DailyMed (National Library of Medicine), updated Jan 21, 2020
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