NDC 71610-129
Montelukast Sodium 10 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Aurobindo Pharma Limited's NDC 65862-574.
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 |
| Aurolife Pharma LLC | Dayton, NJ, United States | Makes it and tests it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
| Aurolife Pharma LLC | Dayton, NJ, United States | Packages it and labels it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- tablet, film coated
- Strength
- 10 mg
- Approval
- ANDA ANDA202468
- On the market since
- Aug 3, 2012
- Package NDCs
71610-129-0971610-129-30- Official label
- DailyMed (National Library of Medicine), updated Sep 11, 2018
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