NDC 68462-319
Ranolazine 500 mg tablet, film coated, extended release
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 # 17240040, exp. date Dec-25 - Oct 23, 2023 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: Out of specification for dissolution.
Lots: Lot # 17230388, Exp. 01/31/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ranolazine: every company that makes it
- Form
- tablet, film coated, extended release, oral
- Strength
- 500 mg
- Approval
- ANDA ANDA211082
- On the market since
- Jul 5, 2019
- Package NDCs
68462-319-0568462-319-60- Official label
- DailyMed (National Library of Medicine), updated Jan 23, 2026
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