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Treats tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Sold as Dilantin-125, Dilantin-30. Every FDA application for this active ingredient: 1 branded and 8 generic.
As of Nov 14, 2026, FDA lists 9 applications for Phenytoin (sold as Dilantin-125, Dilantin-30), first approved Jan 6, 1953, with 0 new uses approved and 0 published complete response letters.
First approved: Jan 6, 1953
Applications: 9
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $30.4M
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Dilantin
Part D
$26.9M
-10%
18,001
Phenytoin
Part D
$3.4M
-5%
12,150
Dilantin-125
Part D
$144K
-4%
216
Phenytoin Sodium
Part D
$3K
+2%
0
PHENYTOIN SODIUM
Part B
$0K
New
0
What Pharmacies Pay
Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change
PHENYTOIN 125 MG/5 ML SUSP: $0.074 per MLGeneric · +13% in a year
PHENYTOIN 50 MG INFATAB CHEW: $0.232 per unitGeneric · +18% in a year
PHENYTOIN 50 MG TABLET CHEW: $0.232 per unitGeneric · +18% in a year
FDA Drug Safety Communications
One communication since 2020 that name this drug; see all communications
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Viatris
Pharmacia
Taro