SPL Set ID: 6d85f252-307c-4aa8-9572-1e74c9819283
1 drug(s) with this SPL Set ID
Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/ 0.03 mg provide an oral contraceptive regimen consisting of 28 film-coated tablets that contain the ingredients specified for each tablet below: • 21 light yellow to yellow tablets each containing 3 mg DRSP and 0.03 mg EE • 7 inert white to off-white tablets The inactive ingredients in the light yellow to yellow tablets are corn starch, crospovidone, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide. The white to off-white inert film-coated tablets contain anhydrous lactose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide. Drospirenone, USP (6R, 7R, 8R, 9S, 10R, 13S, 14S, 15S, 16S, 17S)-1,3’,4’,6, 6a, 7, 8, 9, 10, 11, 12, 13, 14, 15, 15a, 16-hexadecahydro10, 13-dimethylspiro-[17H-dicyclopropa-[6 ,7:15, 16] cyclopenta[a]phenanthrene-17, 2’(5H)-furan]-3, 5’(2H)-dione) is a synthetic progestational compound and has a molecular weight of 366.49 and a molecular formula of C 24 H 30 O 3 . Ethinyl estradiol, USP (19-nor-17α-pregna 1,3,5(10)-triene-20-yne-3, 17-diol) is a synthetic estrogenic compound and has a molecular weight of 296.4 and a molecular formula of C 20 H 24 O 2 . The structural formulas are as follows: Drospirenone, USP Ethinyl Estradiol, USP USP Dissolution Test pending. drospirenone structure ethinylestradiolstructure