SPL Set ID: 90224073-178d-7ec5-e053-2995a90a20fc

Duloxetine delayed-release capsules, USP are a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18 H19 NOS•HCl, which corresponds to a molecular weight of 333.87. The structural formula is: Duloxetine hydrochloride, USP is a white or almost white powder, which is sparingly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, USP equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, shellac, sucrose, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, triethyl citrate, yellow iron oxide, propylene glycol and FD&C Blue No. 1. Additionally, the 20 mg capsules contain FD&C Yellow No. 10; the 30 mg capsules contain FD&C Red No. 3 and simethicone; and the 60 mg capsules also contain FD&C Red No. 3. structural formula