NDC 45865-963
topiramate 50 mg tablet, film coated
On the label: Medsource Pharmaceuticals. It's repackaged: Medsource Pharmaceuticals rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-139.
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
- Medsource Pharmaceuticals, Rancho Santa Margarita, CA, 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
- 50 mg
- Approval
- ANDA ANDA078235
- On the market since
- Mar 27, 2009
- Package NDCs
45865-963-3045865-963-60- Official label
- DailyMed (National Library of Medicine), updated Dec 30, 2019
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