SPL Set ID: 3ea7612b-b004-43ef-accc-34c8ec5146b8
1 drug(s) with this SPL Set ID
Tadalafil 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 389.40. 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)- 1,3 . It is a crystalline solid that is practically insoluble in water, freely soluble in dimethylsulfoxide and slightly soluble in methylene chloride. Tadalafil tablets USP are available as oval shaped, biconvex beveled edge, film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil USP and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry ® II Yellow, and sodium lauryl sulfate. The color coating material contains following ingredients. Strength Coating material Ingredients 2.5 mg Opadry ® II Yellow HPMC 2910 / Hypromellose, Iron oxide red, Iron oxide yellow, Lactose monohydrate, Talc, Titanium dioxide, Triacetin. 5 mg Opadry ® II Yellow HPMC 2910 / Hypromellose, Iron oxide yellow, Lactose monohydrate, Talc, Titanium dioxide, Triacetin. 10 mg 20 mg Structural formula