SPL Set ID: 3e608414-5e64-4c69-a9e0-365904cf7df8
1 drug(s) with this SPL Set ID
Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules contain norethindrone acetate, USP a progestin, and ethinyl estradiol, USP an estrogen. Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules 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, USP and 20 mcg ethinyl estradiol, USP. • 4 oval, opaque, maroon, capsules each containing 75 mg ferrous fumarate, USP. Each pink active capsule also contains the following inactive ingredients: sesame oil, corn oil PEG-6 esters, DL-α-tocopherol, dehydrated alcohol, bovine 150 bloom gelatin, sorbitol sorbitan solution, glycerin, FD&C Red #40, and titanium dioxide. Each maroon non-hormonal placebo capsule contains ferrous fumarate, soybean oil, soybean lecithin, yellow beeswax, bovine 150 bloom gelatin, sorbitol sorbitan solution, glycerin, FD&C Blue #1, FD&C Red #40 and titanium dioxide. The ferrous fumarate capsules do not serve any therapeutic purpose. The chemical name of ethinyl estradiol, USP 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, USP 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: ethinylestradiol norethindroneacetate