lacosamide 150 mg
1 INDICATIONS AND USAGE Lacosamide tablets are indicated for: Treatment of partial-onset seizures in patients 4 years of age and older (1.1) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2) 1.1 Partial-Onset Seizures Lacosamide tablets are indicated for the Treatment of partial-onset seizures in patients 4 years of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
amneal pharmaceuticals llc
OVAL BROWN A925
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
LACOSAMIDE tablets, USP 50 mg are supplied as pink, oval shaped, film-coated tablets debossed with "A93" on one side and plain on the other side. They are available as follows: Bottles of 60: NDC 65162-923-06 Bottles of 500: NDC 65162-923-50
LACOSAMIDE tablets, USP 100 mg are supplied as dark yellow, oval shaped, film-coated tablets debossed with "A924" on one side and plain on the other side. They are available as follows: Bottles of 60: NDC 65162-924-06 Bottles of 500: NDC 65162-924-50
LACOSAMIDE tablets, USP 150 mg are supplied as beige, oval shaped, film-coated tablets debossed with "A925" on one side and plain on the other side. They are available as follows: Bottles of 60: NDC 65162-925-06 Bottles of 500: NDC 65162-925-50
LACOSAMIDE tablets, USP 200 mg are supplied as blue, oval shaped, film-coated tablets debossed with "A926" on one side and plain on the other side. They are supplied as follows: Bottles of 60: NDC 65162-926-06 Bottles of 500: NDC 65162-926-50 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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