NDC 63187-626
Montelukast 5 mg tablet, chewable
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Hikma Pharmaceuticals USA Inc.'s NDC 0143-9650.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it, tests it and packages it | No problems foundAug 30, 2019 · 6 inspections |
| Kemwell Biopharma Private Limited | Location not on file | Makes it, tests it and packages it | Not inspected on record |
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
- 5 mg
- Approval
- ANDA ANDA203037
- On the market since
- Dec 1, 2014
- Package NDCs
63187-626-3063187-626-6063187-626-90- Official label
- DailyMed (National Library of Medicine), updated Nov 1, 2019
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