NDC 10544-489
Topiramate 100 mg tablet, film coated
On the label: Blenheim Pharmacal, Inc.. It's repackaged: Blenheim Pharmacal, Inc. rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-109.
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
- Blenheim Pharmacal, Inc., North Blenheim, New York, United States · repackages it and relabels it
Recalls
- Apr 5, 2013 · Class III · Glenmark Generics Inc., USA
Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.
Lots: Lot# 02123782, Exp 11/14
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Topiramate: every company that makes it
- Form
- tablet, film coated
- Strength
- 100 mg
- Approval
- ANDA ANDA077627
- On the market since
- Oct 8, 2013
- Package NDCs
10544-489-3010544-489-6010544-489-90- Official label
- DailyMed (National Library of Medicine), updated Dec 31, 2013
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