The short version
7 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Extended Phenytoin Sodium
Phenytoin Sodium · PHENYTOIN SODIUM 100 mg/1 · Capsule · Oral · Amneal Pharmaceuticals LLC
NDC 65162-0212-03 · 30 CAPSULE in 1 BOTTLE · ANDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.2%chance of a new FDA shortage posting for phenytoin sodium (oral solid) in the next 90 days
OAI inspection at a producing facility (24 months) · sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
Where it's made
- Amneal Pharmaceuticals of New York, LLCUnited Statesanalysis · label · manufacture · pack
- Amneal Pharmaceuticals of New York, LLCUnited Statesanalysis · label · manufacture · pack
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
Regulatory
- Application
- ANDA040765
- TE code
- AB
- Approval date
- Nov 12, 2008
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class II · TerminatedOct 27, 2023Amneal Pharmaceuticals of New York, LLC — Failed Dissolution Specifications
- Class II · TerminatedMay 30, 2023Amneal Pharmaceuticals of New York, LLC — Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
- Class II · TerminatedAug 17, 2013Amneal Pharmaceuticals of New York, LLC. — Failed dissolution specifications; 18 month CRT
Manufacturers of Phenytoin Sodium (Capsule)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Aurobindo Pharma Limited | PHENYTOIN SODIUM 100 mg/1 | Jul 15, 2026 | Sep 3, 2026 |
| American Health Packaging | PHENYTOIN SODIUM 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals LLC | PHENYTOIN SODIUM 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Bryant Ranch Prepack | PHENYTOIN SODIUM 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Direct Rx | PHENYTOIN SODIUM 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| NCS HealthCare of KY, LLC dba Vangard Labs | PHENYTOIN SODIUM 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Remedyrepack Inc. | PHENYTOIN SODIUM 100 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Extended Phenytoin Sodium — NDC 65162-0212-03," retrieved September 3, 2026, https://drugdashboards.com/drug/65162021203.
Free to cite with attribution — see how the data is put together.