SPL Set ID: 6ca786fb-8f28-d2ac-5d8d-a14c3af6d7a7

1 drug(s) with this SPL Set ID

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Gemmily NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
XIROMED, LLC FDA Rx Only

Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules contain norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen. Gemmily provides an oral contraceptive regimen consisting of 24 pink active soft gelatin capsules that contain the active ingredients, followed by 4 maroon non-hormonal placebo soft gelatin capsules as specified below: 24 oval, opaque, pale pink soft gelatin capsules each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. 4 oval, opaque, maroon, capsules each containing 75 mg ferrous fumarate Each pink active capsule also contains the following inactive ingredients: sesame oil, linoleoyl polyoxylglycerides, DL-α-tocopherol, dehydrated alcohol, gelatin, sorbitol glycerin, FD&C Red #40, purified water, and titanium dioxide. Each maroon non-hormonal placebo capsule contains ferrous fumarate, soybean oil, lecithin, beeswax, gelatin, sorbitol, glycerin, FD&C Blue #1, FD&C Red #40, purified water, and titanium dioxide. The ferrous fumarate capsules do not serve any therapeutic purpose. The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The empirical formula of ethinyl estradiol is C 20 H 24 O 2 and the structural formula is: The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The empirical formula of norethindrone acetate is C 22 H 28 O 3 and the structural formula is: The following structural formula for The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17a)-]. The empirical formula of ethinyl estradiol is C20H24O2. The following structural formula for The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17a)-]. The empirical formula of norethindrone acetate is C22H28O3.

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