NDC 55289-469
Indomethacin 75 mg capsule, extended release
On the label: PD-Rx Pharmaceuticals, Inc.. It's repackaged: PD-Rx Pharmaceuticals, Inc. 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
- PD-Rx Pharmaceuticals Inc., Oklahoma City, OK, United States · repackages it
Recalls
- 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 6, 2009
- Package NDCs
55289-469-10- Official label
- DailyMed (National Library of Medicine), updated May 5, 2025
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