SPL Set ID: 6d8dbaa6-d61a-46ae-a641-f664104f4714

Sildenafil citrate, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo[4,3- d ] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Tablets, USP are formulated as round shaped, blue colored (mottled), biconvex, uncoated, tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, anhydrous dibasic calcium phosphate, sucralose, peppermint flavor (arabic gum & natural flavors), bubblegum flavor (arabic gum, natural & artificial flavors), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, FD&C blue no. 1 aluminum lake, povidone. structure