FDA label
What is phenytoin used for?
The FDA-approved uses of phenytoin, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.”
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Phenytoin Sodium, capsule, extended release
Indications and Usage, quoted from the label by Sun Pharmaceutical Industries, Inc. (ANDA040684). Cross-references to other label sections are left out.
Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Source: DailyMed label, set id 601f7353-225d-4a5d-9810-3869c2c21874, version 16, effective March 17, 2026. NDC 51672-4111, one of 21 listings for this product.
Phenytoin Sodium, injection
Indications and Usage, quoted from the label by Acella Pharmaceuticals, LLC (ANDA040573). Cross-references to other label sections are left out.
Parenteral Phenytoin Sodium Injection is indicated for the treatment of generalized tonic-clonic status epilepticus, and prevention and treatment of seizures occurring during neurosurgery. Intravenous Phenytoin Sodium Injection can also be substituted, as short-term use, for oral phenytoin. Parenteral Phenytoin should be used only when oral phenytoin administration is not possible.
Source: DailyMed label, set id 6922f32f-8bed-4c09-8103-27987bcbd104, version 7, effective September 16, 2024. NDC 42192-614, one of 11 listings for this product.
Phenytoin, tablet, chewable
Indications and Usage, quoted from the label by Parke-Davis Div of Pfizer Inc (ANDA084427). Cross-references to other label sections are left out.
DILANTIN INFATABS are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Source: DailyMed label, set id ca119a89-2394-4d34-8078-cd1fa4e8e2f1, version 58, effective May 12, 2026. NDC 0071-0007, one of 9 listings for this product.
Questions
What is phenytoin used for?
The FDA label says: “Extended phenytoin sodium capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.”
What drug class is phenytoin?
FDA lists phenytoin in the Anti-epileptic Agent established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Phenytoin
- Is Phenytoin a controlled substance?Federal schedule
- Generic for DilantinFDA Orange Book
- Generic for Dilantin-125FDA Orange Book
- What is Dilantin used for?FDA label uses
- Is Dilantin a controlled substance?Federal schedule
- What is Phenytek used for?FDA label uses
- Is Phenytek a controlled substance?Federal schedule
- Anti-epileptic Agents listFDA drug class
- NDC 58151-115Phenytoin NDC record
- NDC 0071-0007Phenytoin NDC record
- NDC 0121-0892Phenytoin NDC record