NDC 43063-381
Montelukast Sodium 4 mg tablet, chewable
On the label: PD-Rx Pharmaceuticals, Inc.. It's repackaged: PD-Rx Pharmaceuticals, Inc. rebottles it from Torrent Pharma, Inc.'s NDC 13668-079.
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
- PD-Rx Pharmaceuticals Inc., Oklahoma City, OK, United States · repackages it
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- tablet, chewable, oral
- Strength
- 4 mg
- Approval
- ANDA ANDA090984
- On the market since
- Aug 3, 2012
- Package NDCs
43063-381-2143063-381-30- Official label
- DailyMed (National Library of Medicine), updated Sep 22, 2026
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