SPL Set ID: 793928fb-fbcb-4fc6-90d4-f8a15e6b1f93

Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride, USP is the R (-) isomer as determined by x-ray diffraction. The chemical designation is (-)- N -Methyl-3-phenyl-3-( o -tolyloxy)-propylamine hydrochloride. The molecular formula is C 17 H 21 NO•HCl, which corresponds to a molecular weight of 291.82 g/mol. The chemical structure is: Atomoxetine hydrochloride, USP is a white to off-white crystalline powder; sparingly soluble in water. Atomoxetine Capsules USP are intended for oral administration only. Each capsule contains atomoxetine hydrochloride USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch. The capsule shell for Atomoxetine Capsules USP, 10 mg contains gelatin, and titanium dioxide. The capsule shell for Atomoxetine Capsules USP, 18 mg contains D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide. The capsule shell for Atomoxetine Capsules USP, 25 mg and 40 mg contains D&C Red No. 28, FD&C Blue No.1, gelatin, and titanium dioxide. The capsule shell for Atomoxetine Capsules USP, 60 mg contains D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide. The capsule shell for Atomoxetine Capsules USP, 80 mg and 100 mg contains D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, gelatin, and titanium dioxide. The imprinting ink for Atomoxetine Capsules USP, 10 mg, 25 mg, 40 mg, 80 mg and 100 mg has the following components: black iron oxide, D&C Yellow No. 10, FD&C Blue No. 2, FD&C Blue No. 1, FD&C Red No. 40, propylene glycol, and shellac. The imprinting ink for Atomoxetine Capsules USP, 18 mg and 60 mg has the following components: black iron oxide, propylene glycol, potassium hydroxide, strong ammonia solution, and shellac. Structure.jpg