NDC 68462-714
rufinamide 400 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 # 17231643, exp. date Jul-25 17231644, exp. date Jul-25
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Rufinamide: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 400 mg
- Approval
- ANDA ANDA205075
- On the market since
- May 16, 2016
- Package NDCs
68462-714-0568462-714-08- Official label
- DailyMed (National Library of Medicine), updated Jan 23, 2026
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