NDC 70518-2001
topiramate 200 mg tablet, film coated
On the label: Remedyrepack Inc.. It's repackaged: Remedyrepack Inc. rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-141.
Where the pills inside were 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 |
Recalls
- Sep 15, 2014 · Class II · Zydus Pharmaceuticals USA Inc
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Lots: Lot #: MN9828, Expiry: Oct 2015.
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
- 200 mg
- Approval
- ANDA ANDA078235
- On the market since
- Apr 3, 2019
- Package NDCs
70518-2001-070518-2001-170518-2001-270518-2001-370518-2001-470518-2001-570518-2001-6- Official label
- DailyMed (National Library of Medicine), updated Jul 8, 2026
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