NDC 63187-118
Topiramate 25 mg tablet, film coated
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP rebottles it from Glenmark Pharmaceuticals Inc., USA's NDC 68462-108.
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
- Proficient Rx LP, Thousand Oaks, CA, 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, oral
- Strength
- 25 mg
- Approval
- ANDA ANDA077627
- On the market since
- Mar 27, 2009
- Package NDCs
63187-118-3063187-118-6063187-118-90- Official label
- DailyMed (National Library of Medicine), updated Jan 1, 2021
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