NDC 61919-883
Topiramate 25 mg tablet, film coated
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-138.
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 |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
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
- Strength
- 25 mg
- Approval
- ANDA ANDA078235
- On the market since
- May 31, 2019
- Package NDCs
61919-883-3061919-883-6061919-883-86- Official label
- DailyMed (National Library of Medicine), updated Mar 15, 2023
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