NDC 53808-1040
Extended Phenytoin Sodium 100 mg capsule
On the label: State of Florida DOH Central Pharmacy. It's repackaged: State of Florida DOH Central Pharmacy rebottles it from Amneal Pharmaceuticals's NDC 65162-212.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals of New York, LLC | Hauppauge, NY, United States | Makes it, tests it, packages it and labels it | No problems foundFeb 3, 2020 · 12 inspections |
| Amneal Pharmaceuticals of New York, LLC | Brookhaven, NY, United States | Makes it, tests it, packages it and labels it | No problems foundSep 25, 2026 · 14 inspections |
Repackaging site
- State of Florida DOH Central Pharmacy, Location not on file · repackages it
Recalls
- Oct 27, 2023 · Class II · Amneal Pharmaceuticals of New York, LLC
Failed Dissolution Specifications
Lots: Lot # HM03221A, Exp. date 12/31/2023 - May 30, 2023 · Class II · Amneal Pharmaceuticals of New York, LLC
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Lots: Lot # HL00721A, Exp. 12/2023 - Aug 17, 2013 · Class II · Amneal Pharmaceuticals of New York, LLC.
Failed dissolution specifications; 18 month CRT
Lots: Batch/Lot HL50611, exp. 1/2014
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Phenytoin: every company that makes it
- Form
- capsule
- Strength
- 100 mg
- Approval
- ANDA ANDA040765
- On the market since
- Jan 1, 2014
- Package NDCs
53808-1040-2- Official label
- DailyMed (National Library of Medicine), updated Sep 30, 2014
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