SPL Set ID: 1dace1e7-c617-492f-bb0d-141bf4e673db

1 drug(s) with this SPL Set ID

Open DailyMed details

Tadalafil TADALAFIL
5 mg Tablet
ANI PHARMACEUTICALS, INC. FDA Rx Only

Tadalafil 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 practically insoluble in water and very slightly soluble in ethanol. Tadalafil Tablets, USP are available for oral administration. Each tablet contains 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: lactose monohydrate, croscarmellose sodium, FD&C blue #1 aluminum lake, sodium lauryl sulfate, hydroxypropyl cellulose, mannitol, fructose, colloidal silicon dioxide, crospovidone, microcrystalline cellulose, sucralose, bubblegum flavor (arabic gum, natural and artificial flavor) and magnesium stearate. FDA approved dissolution test specifications differ from USP. structure

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