SPL Set ID: a8955f3b-afc9-4ef0-8946-9c97ab5b2e05
1 drug(s) with this SPL Set ID
Drospirenone and ethinyl estradiol tablets USP, 3 mg and 0.03 mg, provide an oral contraceptive regimen consisting of 28 tablets that contain the ingredients specified for each tablet below: 21 yellow film-coated tablets each containing 3 mg DRSP and 0.03 mg EE 7 inert white to off-white tablets The inactive ingredients in the yellow tablets are corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc, titanium dioxide and yellow iron oxide. The inert white to off-white tablets contains corn starch, lactose monohydrate, magnesium stearate, and pregelatinized starch. FDA approved dissolution test specifications differ from USP. Drospirenone (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-hexadecahydro-10,13-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 366.5 and a molecular formula of C 24 H 30 O 3 . Ethinyl estradiol (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: Structure Formula