lacosamide 200 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 tablets are 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 pediatric information.
Ascend Laboratories, LLC
OVAL BLUE LAC 200
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
LACOSAMIDE Tablets, USP 50 mg are pink, oval shaped, film coated tablets debossed with "LAC" on one side and "50" on other side. They are supplied as follows: Bottles of 60 NDC 67877-733-60 Bottles of 90 NDC 67877-733-90 Bottles of 500 NDC 67877-733-05 Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 67877-733-31 100 mg are dark yellow, oval shaped, film coated tablets debossed with "LAC" on one side and "100" on other side. They are supplied as follows: Bottles of 60 NDC 67877-734-60 Bottles of 90 NDC 67877-734-90 Bottles of 500 NDC 67877-734-05 Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 67877-734-31 150 mg are peach, oval shaped, film coated tablets debossed with "LAC" on one side and "150" on other side. They are supplied as follows: Bottles of 60 NDC 67877-735-60 Bottles of 90 NDC 67877-735-90 Bottles of 500 NDC 67877-735-05 Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 67877-735-31 200 mg are blue, oval shaped, film coated tablets debossed with "LAC" on one side and "200" on other side. They are supplied as follows: Bottles of 60 NDC 67877-736-60 Bottles of 90 NDC 67877-736-90 Bottles of 500 NDC 67877-736-05 Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 67877-736-31 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]
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