SPL Set ID: e19acee5-ff33-45a5-bbbf-801756bc59b4

Danazol, USP is a synthetic steroid derived from ethisterone. It is a white to pale yellow crystalline powder, practically insoluble or insoluble in water, and sparingly soluble in alcohol. Chemically, danazol, USP is 17α-Pregna-2,4-dien-20-yno [2,3- d ]-isoxazol-17-ol, which has the following structural formula: C 22 H 27 NO 2 M.W. 337.46 Danazol capsules, USP for oral administration, contain 50 mg, 100 mg or 200 mg of danazol, USP. In addition, each capsule contains the following inactive ingredients: black iron oxide, D&C yellow no. 10, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, gelatin, lactose monohydrate, magnesium stearate, pharmaceutical glaze, propylene glycol, sodium starch glycolate, stearic acid and titanium dioxide The 50 mg and 100 mg capsule shells also contain FD&C yellow no. 6. The 200 mg capsule shell also contains FD&C red no. 40 and D&C red no. 28. Structural Formula