Drug Information for FLUOXETINE TABLETS USP, 10 mg7188Rx only (Teva Pharmaceuticals USA): DESCRIPTION

Fluoxetine tablets are a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem^®, fluoxetine hydrochloride). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro-p-tolyl) oxy]propylamine hydrochloride and has the following structural formula:

C₁₇H₁₈F₃NO•HCl M.W. 345.79

Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.

Each tablet contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol) of fluoxetine. In addition, each tablet also contains the following inactive ingredients: D&C Yellow #10, FD&C Blue #2, FD&C Yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, talc, and titanium dioxide.