SPL Set ID: fbe58138-8e26-c4d9-e053-6294a90a3bd0

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 C 18 H 19 NOS•HCl, which corresponds to a molecular weight of 333.88. The structural formula is: Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres (sucrose and maize starch), hypromellose, sucrose, talc, hydroxypropyl methylcellulose acetate succinate, triethyl citrate, polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol/peg and gelatin. The 30 mg capsules also contain FD&C Blue 1 and D&C Yellow 10. The 60 mg capsules also contain FD&C Blue 1 and FD&C Red 3. Chemical Structure