NDC 68462-678
lacosamide 50 mg tablet, film coated
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Dhar, India | Makes it and tests it | Serious problems, FDA actionFeb 14, 2025 · 8 inspections, 1 with FDA action |
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17230982, exp. date Apr-25 17230986, exp. date, Apr-25 17231001, exp. date, Apr-25 17240197, exp. date Jan-26 17240198, exp. date Jan-26 17240215, exp. date Jan-26 17240846, exp. date Apr-26 17240847, exp. date Apr-26 - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17232533, exp. date Nov-25 17232534, exp. date Nov-25 17240606, exp. date Mar-26 17240619, exp. date Mar-26 17240911, exp. date May-26 17240912, exp. date May-26 17241121, exp. date Jun-26 17241124, exp. date Jun-26 - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17240221, exp. date Jan-26 17240222, exp. date Jan-26 - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: Lot # 17241125, exp. date Jun-26 17242202, exp. date Nov-26 17242204, exp. date Dec-26
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Lacosamide: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA205006
- On the market since
- Mar 18, 2022
- Package NDCs
68462-678-1068462-678-3068462-678-60- Official label
- DailyMed (National Library of Medicine), updated Dec 17, 2025
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