NDC 68462-325
indomethacin 75 mg capsule, 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 # 17232323, exp. date Oct-25 17232335, exp. date Oct-25 17232323, exp. date Oct-25 - Jul 31, 2024 · Class II · Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: below specification results
Lots: Lot#: 17240105, Exp 12/31/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Indomethacin: every company that makes it
- Form
- capsule, extended release, oral
- Strength
- 75 mg
- Approval
- ANDA ANDA203501
- On the market since
- Jun 22, 2017
- Package NDCs
68462-325-0168462-325-0568462-325-1068462-325-6068462-325-90- Official label
- DailyMed (National Library of Medicine), updated Dec 3, 2025
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?