NDC 68084-411
Indomethacin 75 mg capsule, extended release
On the label: American Health Packaging. It's repackaged: American Health Packaging rebottles it from KVK-TECH, Inc.'s NDC 10702-016.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Kvk-Tech, Inc. | Newtown, PA, United States | Makes it | Serious problems, FDA actionMar 14, 2025 · 13 inspections, 3 with FDA action |
Repackaging site
- American Health Packaging, Columbus, OH, United States · repackages it
Recalls
- May 15, 2025 · Class II · Amerisource Health Services LLC
cGMP deviations
Lots: Lot #: 1021950, Exp. 11/30/2026 - May 9, 2025 · Class II · KVK Tech, Inc.
cGMP deviations
Lots: Lot#: 18400A, Exp 7/31/2027
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 ANDA079175
- On the market since
- Mar 26, 2010
- Package NDCs
68084-411-1168084-411-21- Official label
- DailyMed (National Library of Medicine), updated Oct 28, 2025
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