NDC 61919-164
Indomethacin 50 mg capsule
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-302.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Nov 7, 2023 · Class II · Glenmark Pharmaceuticals Inc., USA
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Lots: Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484; Exp 8/2025 Lot# 19233490; Exp 8/2025 - Mar 19, 2018 · Class III · Glenmark Pharmaceuticals Inc., USA
Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Lots: Lot #: 19172776, 19172794, Exp 07/19; 19173111, 19173186, 19173188, 19173189, Exp 08/19; 19173852, 19173878, 19173893, Exp 10/19; 19174318, 19174341, Exp 11/19.
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, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA091276
- On the market since
- Apr 20, 2017
- Package NDCs
61919-164-2161919-164-30- Official label
- DailyMed (National Library of Medicine), updated Apr 2, 2024
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