SPL Set ID: 88132351-7fee-47ef-8007-ef2777543299

1 drug(s) with this SPL Set ID

Open DailyMed details

TADALAFIL TADALAFIL
20 mg Tablet
TORRENT PHARMACEUTICALS LIMITED FDA Rx Only

Tadalafil USP, an oral treatment for pulmonary arterial hypertension, 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)-. 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 yellow colored, oval shaped, biconvex beveled edge, film coated tablets for oral administration. Each tablet contains 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 20 mg Opadry ® II Yellow HPMC 2910 / Hypromellose, Iron oxide yellow, Lactose monohydrate, Talc, Titanium dioxide, Triacetin. Meets USP dissolution Test 2. Structural Formula

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