NDC 72189-339
Oxcarbazepine 150 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 62756-183.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Sun Pharmaceutical Industries Limited | Halol, India | Makes it and tests it | Serious problems, FDA actionJun 13, 2025 · 12 inspections, 5 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · relabels it
Recalls
- Dec 1, 2022 · Class II · Sun Pharmaceutical Industries Inc
Presence of foreign substance
Lots: a) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023 - Jan 29, 2014 · Class II · Caraco Pharmaceutical Laboratories Ltd.
Failed Tablet Specifications: Broken Tablets Present.
Lots: Lot #: JKM7075A, Expiry:10/15
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Oxcarbazepine: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 150 mg
- Approval
- ANDA ANDA077794
- On the market since
- Apr 5, 2022
- Package NDCs
72189-339-60- Official label
- DailyMed (National Library of Medicine), updated Jan 22, 2025
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