SPL Set ID: 1a1da905-42a0-4748-9c39-67eca45deccc

Focalin XR contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin XR is an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled Focalin XR 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. Focalin XR is 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 copolymer, polyethylene glycol, sugar spheres, talc, titanium dioxide, and triethyl citrate. Each strength capsule also contains colorant ingredients in the capsule shell as follows: • 5 mg: E132 FD&C Blue No. 2 • 10 mg: FDA/E172 iron oxide yellow • 15 mg: FD&C Blue No. 2, FDA/E172 iron oxide yellow • 20 mg: contains no colorants • 25 mg: E132 FD&C Blue No. 2 • 30 mg: FDA/E172 iron oxide yellow • 35 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow • 40 mg: E132 FD&C Blue No. 2, FDA/E172 iron oxide yellow Dexmethylphenidate hydrochloride structural formula.