SPL Set ID: 2a6581fc-d458-4bb3-97fa-2179405599ca
1 drug(s) with this SPL Set ID
Fluoxetine Capsules USP are a selective serotonin reuptake inhibitor for oral administration. They are 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: C 17 H 18 F 3 NO•HCl M.W. 345.79 Fluoxetine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride, USP equivalent to 40 mg (129.3 μmol) of fluoxetine. In addition, the capsules also contain the following inactive ingredients: colloidal silicon dioxide, pregelatinized corn starch, and simethicone. The capsule shell contains D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, gelatin, and titanium dioxide. The imprinting ink contains FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, D&C Yellow #10 aluminum lake, iron oxide black and shellac glaze, and may contain propylene glycol. This product meets USP Dissolution Test 2. Chemical structure