levetiracetam

FDA Drug Profile — Spritam, Keppra XR, LEVETIRACETAM, Levetiracetam Extended-Release, Levetiracetam

levetiracetam is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including Spritam, Keppra XR, LEVETIRACETAM. Available dosage forms: tablet, for suspension, tablet, film coated, extended release, injection, injection, solution, concentrate, tablet, film coated.

Drug Details

Generic Name
levetiracetam
Brand Names
Spritam, Keppra XR, LEVETIRACETAM, Levetiracetam Extended-Release, Levetiracetam, levetiracetam, ELEPSIA XR 1500 MG, Keppra, ELEPSIA XR 1000 MG
Application Number
NDA207958
Sponsor
Aprecia Pharmaceuticals, LLC
NDC Codes
50
Dosage Forms
TABLET, FOR SUSPENSION, TABLET, FILM COATED, EXTENDED RELEASE, INJECTION, INJECTION, SOLUTION, CONCENTRATE, TABLET, FILM COATED, INJECTION, SOLUTION, SOLUTION, TABLET, EXTENDED RELEASE, POWDER
Routes
ORAL, INTRAVENOUS
Active Ingredients
LEVETIRACETAM

Indications and Usage

1 INDICATIONS AND USAGE Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) 1.1 Partial-Onset Seizures Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures Levetiracetam is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.