SPL Set ID: 887fc670-db67-4cfe-967b-46b38375dae5
1 drug(s) with this SPL Set ID
Fluoxetine delayed-release capsules USP is a selective serotonin reuptake inhibitor 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 molecular formula of C 17 H 18 F 3 NO•HCl. Its molecular weight is 345.79. The structural formula is: Fluoxetine hydrochloride USP is a white to off-white crystalline powder. Sparingly soluble in purified water and in methylene chloride; freely soluble in methanol and in alcohol. Practically insoluble in ether. Each delayed release capsule, for oral administration contains white to off-white elliptical to spherical enteric-coated pellets of fluoxetine hydrochloride equivalent to 90 mg (291 µmol) of fluoxetine. The capsules also contain black iron oxide, copovidone, gelatin, glycine, hypromellose, hypromellose phthalate, isopropyl alcohol, methylene chloride, red iron oxide, sugar globules, talc, titanium dioxide, triethyl citrate and yellow iron oxide.