SPL Set ID: 570670c0-b88f-4e78-a978-498aff52b410
1 drug(s) with this SPL Set ID
Norethindrone Acetate and Ethinyl Estradiol Tablets USP and Ferrous Fumarate Tablets USP provides 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 to off-white, round, flat faced beveled edge, uncoated tablets debossed with “21” on one side and “Y” on the other side each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP • 4 brown to dark brown, round, flat faced beveled edge, uncoated tablets debossed with “18” on one side and “G” on the other side each containing 75 mg ferrous fumarate Each white active chewable tablet also contains the following inactive ingredients: acacia, corn starch, lactose monohydrate, magnesium stearate, spearmint flavor, sucralose, sucrose and talc. Each brown placebo tablet contains acacia, corn starch, ferrous fumarate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, sucralose and talc. The ferrous fumarate tablets do not serve any therapeutic purpose. The empirical formula of ethinyl estradiol, USP is C 20 H 24 O 2 and the structural formula is: The chemical name of ethinyl estradiol, USP is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The molecular weight of ethinyl estradiol, USP is 296.40. The empirical formula of norethindrone acetate, USP is C 22 H 28 O 3 and the structural formula is: The chemical name of norethindrone acetate, USP is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The molecular weight of norethindrone acetate, USP is 340.46. EEstructure.jpg NEstructure.jpg