NDC 53002-4730
Montelukast Sodium 5 mg tablet, chewable
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Rising Pharma Holdings, Inc.'s NDC 57237-213.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited | Mahabubnagar, India | Makes it and tests it | Problems found, fixed voluntarilyMay 10, 2022 · 7 inspections, 1 with FDA action |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · repackages it and relabels it
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- tablet, chewable
- Strength
- 5 mg
- Approval
- ANDA ANDA202096
- On the market since
- Aug 3, 2012
- Package NDCs
53002-4730-1- Official label
- DailyMed (National Library of Medicine), updated Mar 30, 2022
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