NDC 68382-557
carbamazepine 400 mg tablet, extended release
On the label: Zydus Pharmaceuticals (USA) Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Ahmedabad, India | Makes it and tests it | Problems found, fixed voluntarilyAug 5, 2022 · 10 inspections, 3 with FDA action |
Product details
- Generic drug
- Carbamazepine: every company that makes it
- Form
- tablet, extended release, oral
- Strength
- 400 mg
- Approval
- ANDA ANDA205571
- On the market since
- Mar 12, 2019
- Package NDCs
68382-557-0168382-557-0668382-557-1668382-557-30- Official label
- DailyMed (National Library of Medicine), updated Aug 4, 2026
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