NDC 68084-875
Montelukast Sodium 10 mg tablet, coated
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from Dr.Reddy's Laboratories Ltd.'s NDC 55111-725.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | Medchal-Malkajgiri, India | Makes it and tests it | Problems found, fixed voluntarilyOct 27, 2023 · 8 inspections |
Repackaging site
- American Health Packaging, Columbus, OH, United States · repackages it
Recalls
- Oct 13, 2023 · Class II · Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Lots: Lot # C2305569, Exp. date 03/31/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Montelukast: every company that makes it
- Form
- tablet, coated, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA201582
- On the market since
- Apr 2, 2015
- Package NDCs
68084-875-0168084-875-11- Official label
- DailyMed (National Library of Medicine), updated Oct 31, 2024
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