SPL Set ID: 39685618-1921-4720-9c00-5ca8fb10a815
1 drug(s) with this SPL Set ID
Finzala ® (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20 mcg and ferrous fumarate tablets) provide an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: 24 white, round, flat-faced, beveled-edge, unscored tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. 4 brown, round, flat-faced, beveled-edge, unscored tablets each containing 75 mg ferrous fumarate, USP. Each white active chewable tablet also contains the following inactive ingredients: acacia, confectioner’s sugar, lactose monohydrate, magnesium stearate, maltodextrin, pregelatinized corn starch, silicon dioxide, spearmint oil, sucralose, and talc. Each brown placebo tablet contains ferrous fumarate USP, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate type A, silicon dioxide, spearmint oil, and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay. The structural formula of ethinyl estradiol, USP is: C 20 H 24 O 2 MW: 296.40 The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The structural formula of norethindrone acetate, USP is: C 22 H 28 O 3 MW: 340.46 The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. FDA approved dissolution test specifications differ from USP. 1 1