NDC 63187-550
Montelukast Sodium 4 mg tablet, chewable
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP 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
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels 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
63187-550-3063187-550-6063187-550-90- Official label
- DailyMed (National Library of Medicine), updated Oct 1, 2023
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