NDC 0904-6172
Carbamazepine 200 mg tablet
On the label: Major Pharmaceuticals. It's repackaged: Major Pharmaceuticals rebottles it from Torrent Pharma, Inc.'s NDC 13668-268.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Torrent Pharmaceuticals Limited | Indrad, India | Makes it | Problems found, fixed voluntarilyJun 12, 2024 · 7 inspections, 2 with FDA action |
| Torrent Pharmaceuticals Limited | Bharuch, India | Makes it, tests it and packages it | No problems foundJan 23, 2026 · 5 inspections, 1 with FDA action |
Recalls
- Dec 2, 2021 · Class II · Torrent Pharma Inc.
Failed Dissolution Specifications
Lots: Batch: 4J11G002 Exp. 08/2024 - Aug 6, 2021 · Class II · The Harvard Drug Group
Failed Dissolution Specifications
Lots: Lot R01562; Exp. 10/2022 - May 11, 2020 · Class II · Torrent Pharma Inc.
Failed Dissolution Specifications
Lots: Lot #: 4FF4F001, Exp 1/2023
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, oral
- Strength
- 200 mg
- Approval
- ANDA ANDA077272
- On the market since
- Sep 20, 2010
- Package NDCs
0904-6172-500904-6172-61- Official label
- DailyMed (National Library of Medicine), updated Sep 16, 2026
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