Zydus Lifesciences Limited
Ahmedabad, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection Aug 5, 2022. 10 inspections on record, 3 with serious problems.
NDC 50436-0139
topiramate 50 mg tablet, film coated
On the label: Unit Dose Services.
It's a repackaged product: Unit Dose Services rebottles it from Zydus Pharmaceuticals (USA) Inc.'s NDC 68382-139.
Where the pills inside were made
Repackaging site
- Unit Dose Services, · repackages it and relabels it
Recalls
- Sep 15, 2014 · Class II · Terminated
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Lots: Lot #: MN9828, Expiry: Oct 2015.
Product details
- Generic drug
- Topiramate: see every company that makes it
- Form
- tablet, film coated
- Strength
- 50 mg
- Approval
- ANDA ANDA078235
- On the market since
- Mar 27, 2009
- Package NDCs
50436-0139-150436-0139-250436-0139-3- Official label
- DailyMed (National Library of Medicine), updated Nov 7, 2017
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