SPL Set ID: e428429e-e1ea-40e1-870f-134533dc3aa1

Duloxetine delayed-release capsules USP are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) 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 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride 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 hypromellose, hypromellose acetate succinate, sugar spheres (containing corn starch), sucrose, talc, triethyl citrate, gelatin, titanium dioxide, brilliant blue FCF - FD&C Blue 1. The 20mg and 60mg capsules also contain erythrosine -FD&C Red 3. FDA approved dissolution test specifications differ from USP. Duloxetine delayed-release capsules USP