SPL Set ID: 0ea97208-5afc-4943-b35c-ea850203a794
1 drug(s) with this SPL Set ID
Tadalafil tablets, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41. The structural formula is: The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is freely soluble in dimethylsulfoxide, slightly soluble in methylene chloride and practically insoluble in water. Tadalafil tablets, USP are available as yellow colored, almond-shaped, biconvex tablets for oral administration. Each tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxy propyl cellulose, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, talc, titanium dioxide, triacetin. Iron oxide red is only present in tadalafil tablets USP, 2.5 mg. FDA approved dissolution test specifications differ from USP. Chemical Structure