SPL Set ID: 6140b3f1-ff60-427c-91d7-15af99fd78f1

1 drug(s) with this SPL Set ID

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Lacosamide LACOSAMIDE
50 mg Tablet
AUROBINDO PHARMA LIMITED FDA Rx Only

The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3-methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C 13 H 18 N 2 O 3 and its molecular weight is 250.30. The chemical structure is: Lacosamide USP is a white to light yellow powder. It is freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile and practically insoluble in heptane. 11.1 Lacosamide Tablets USP Lacosamide tablets USP for oral administration contain lacosamide USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lecithin, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide and dye pigments as specified below: Lacosamide tablets USP are supplied as debossed tablets and contain the following coloring agents: 50 mg tablets: FD&C Blue #2/indigo carmine aluminum lake, iron oxide black, iron oxide red 100 mg tablets: iron oxide yellow 150 mg tablets: iron oxide black, iron oxide red, iron oxide yellow 200 mg tablets: FD&C Blue #2/indigo carmine aluminum lake str

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