SPL Set ID: 759907a1-2da7-47df-bf7f-e642f60b998f

Esterified Estrogens and Methyltestosterone Tablets: Each dark green, capsule shaped, sugar-coated oral tablet imprinted with “1490” contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. Esterified Estrogens and Methyltestosterone Half-Strength Tablets: Each light green, capsule shaped, sugar-coated oral tablet imprinted with “1507” contains: 0.625 mg of Esterified Estrogens, USP and 1.25 mg of Methyltestosterone, USP. Esterified Estrogens Esterified Estrogens, USP is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. Esterified Estrogens contain not less than 75.0 percent and not more than 85.0 percent of sodium estrone sulfate, and not less than 6.0 percent and not more than 15.0 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90.0 percent. Methyltestosterone Methyltestosterone, USP is an androgen. Androgens are derivatives of cyclopentano-perhydrophenanthrene. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. Fluoxymesterone and methyltestosterone are synthetic derivatives of testosterone. Methyltestosterone is a white to light yellow crystalline substance that is virtually insoluble in water but soluble in organic solvents. It is stable in air but decomposes in light. Methyltestosterone structural formula: Esterified Estrogens and Methyltestosterone Full and Half-Strength Tablets contain the following inactive ingredients: acacia, calcium carbonate, carnauba wax, citric acid, colloidal silicon dioxide, di-acetylated monoglycerides, gelatin, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, pharmaceutical glaze, povidone, propylene glycol, propylparaben, shellac glaze, sodium benzoate, sodium bicarbonate, sorbic acid, starch, sucrose, talc, titanium dioxide, tromethamol, FD&C Blue No. 1 Aluminum Lake, and D&C Yellow No. 10 Aluminum Lake. Esterified Estrogens and Methyltestosterone Tablets also contain: FD&C Yellow No. 6 Aluminum Lake. Esterified Estrogens and Methyltestosterone Half-Strength Tablets also contain: FD&C Blue No. 2 Aluminum Lake and Iron Oxide Black.