Levetiracetam 500 MG Oral Tablet
1 INDICATIONS AND USAGE Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of: Partial onset seizures in patients one month of age and older with epilepsy ( 1.1 ) 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 tablets USP are indicated for treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets USP are 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 tablets USP are 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.
Lupin Pharmaceuticals, Inc.
OVAL YELLOW L U X02
L U X02 OVAL YELLOW
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Lupin Pharmaceuticals, Inc
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
LEVETIRACETAM tablets USP, 250 mg are blue coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X01" on the other side. They are supplied as follows: NDC 68180-112-09 Bottles of 90's NDC 68180-112-16 Bottles of 120's NDC 68180-112-02 Bottles of 500's
LEVETIRACETAM tablets USP, 500 mg are yellow coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X02" on the other side. They are supplied as follows: NDC 68180-113-09 Bottles of 90's NDC 68180-113-16 Bottles of 120's NDC 68180-113-02 Bottles of 500's
LEVETIRACETAM tablets USP, 750 mg are orange coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X03" on the other side. They are supplied as follows: NDC 68180-114-09 Bottles of 90's NDC 68180-114-16 Bottles of 120's NDC 68180-114-02 Bottles of 500's
LEVETIRACETAM tablets USP, 1000 mg are white to off-white coloured, oblong-shaped, biconvex, film-coated tablets debossed with "L" and "U" on either side of the breakline on one side and "X04" on the other side. They are supplied as follows: NDC 68180-115-07 Bottles of 60's NDC 68180-115-02 Bottles of 500's 16.2 Storage Store at 25°C (77°F); excursions permitted to 15° C to 30°C (59° F to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with child-resistant closure along with medication guide provided separately.
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