SPL Set ID: 46b09064-a675-92d5-24a7-dac0410f77ae

1 drug(s) with this SPL Set ID

Open DailyMed details

Tasimelteon TASIMELTEON
20 mg Capsule
APOTEX CORP. FDA Rx Only

Tasimelteon is a melatonin receptor agonist, chemically designated as (1 R-trans )- N -[[2-(2,3-Dihydrobenzofuran-4-yl)cycloprop-1-yl]methyl]propanamide, containing two chiral centers. The molecular formula is C 15 H 19 NO 2 , and the molecular weight is 245.32 g/mol. The structural formula is: Tasimelteon is a white to off-white powder. It is very slightly soluble in cyclohexane, slightly soluble in water and freely soluble or very soluble in methanol, 95% ethanol, acetonitrile, isopropanol, propylene glycol and ethyl acetate. Tasimelteon capsules are intended for oral administration. Each capsule contains 20 mg of tasimelteon and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Each hard gelatin capsule consists of FD&C Blue #1, FD&C Red #3, and FD&C Yellow #6, gelatin and titanium dioxide. The imprinting ink consists of povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide.

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