NDC 12634-160
Indomethacin ER 75 mg capsule
On the label: Apotheca, Inc.. It's repackaged: Apotheca, 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 |
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
- Strength
- 75 mg
- Approval
- ANDA ANDA079175
- On the market since
- Mar 4, 2010
- Package NDCs
12634-160-0012634-160-2512634-160-5412634-160-5512634-160-5712634-160-5912634-160-6012634-160-7112634-160-7912634-160-8012634-160-8412634-160-85- Official label
- DailyMed (National Library of Medicine), updated Apr 16, 2010
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