NDC 67046-009
Carbamazepine 200 mg tablet
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Caraco Pharmaceutical Laboratories, Ltd.'s NDC 51672-4005.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Taro Pharmaceutical Industries Ltd. | Haifa Bay, Israel | Makes it and makes the active ingredient | No problems foundDec 8, 2022 · 7 inspections |
Repackaging site
- Coupler Enterprises, Location not on file · repackages it
Recalls
- Aug 3, 2026 · Class II · Sun Pharmaceutical Industries Inc
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Lots: Lot # AD94033, Exp Date: 5/31/2028. - Oct 21, 2014 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.
Lots: Lot 137393, exp. 10/2016
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Carbamazepine: every company that makes it
- Form
- tablet
- Strength
- 200 mg
- Approval
- ANDA ANDA074649
- On the market since
- Oct 3, 1996
- Package NDCs
67046-009-30- Official label
- DailyMed (National Library of Medicine), updated Sep 15, 2017
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