NDC 68462-386
solifenacin succinate 5 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 # 17230762, exp. date Mar-25 - Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Lots: 30 count bottle: 17232395, exp. date Nov-25 17232400, exp. date Nov-25 90-count bottle: 17232395, exp. date Nov-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
- Solifenacin: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA209239
- On the market since
- May 20, 2019
- Package NDCs
68462-386-1468462-386-3068462-386-90- Official label
- DailyMed (National Library of Medicine), updated Jan 28, 2026
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