SPL Set ID: abe6862b-3cf3-4aad-98ea-05a5fb54ebec

Dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and is available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C 14 H 19 NO 2 •HCl. Its structural formula is: Note* = asymmetric carbon center Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients : ammonio methacrylate copolymer, gelatin, methacrylic acid and methyl methacrylate copolymer, polyethylene glycol, sugar spheres (which contain sucrose and starch), talc, titanium dioxide, and triethyl citrate. The 5 mg, 25 mg and 35 mg capsule also contains D&C red #28. The 15 mg and 40 mg capsule also contains D&C yellow #10. The 5 mg, 15 mg, 25 mg, 35 mg, and 40 mg capsule also contains FD&C blue #1. The 10 mg, 30 mg and 35 mg capsule also contains FD&C yellow #6. In addition, capsule imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. dexmethyl-structure-jpg