SPL Set ID: 05a744a5-64ef-42d7-a19c-568be5a272d4

Duloxetine hydrochloride is 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 hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 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, hypromellose, talc, sucrose, hypromellose phthalate, triethyl citrate, FD&C Blue No. 2, titanium dioxide, gelatin, sodium lauryl sulfate. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients: 20 mg: shellac, black iron oxide, potassium hydroxide, propylene glycol and strong ammonia solution 30 mg: shellac, titanium dioxide, yellow iron oxide, FD&C Blue No. 2 Aluminum Lake, propylene glycol and strong ammonia solution 60 mg: shellac, potassium hydroxide, titanium dioxide, propylene glycol and strong ammonia solution duloxetine-structure