norethindrone acetate and ethinyl estradiol and ferrous fumarate - Medication Listings

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

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

Norethindrone acetate and ethinyl estradiol tablets are graduated estrophasic combined oral contraceptive providing estrogen in a graduated sequence over a 21-day period with a constant dose of progestogen. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets provide for a continuous dosage regimen consisting of 21 oral contraceptive tablets and seven ferrous fumarate tablets. The ferrous fumarate tablets are present to facilitate ease of drug administration via a 28-day regimen, are non-hormonal, and do not serve any therapeutic purpose. Each white to off white tablet contains 1 mg norethindrone acetate [(17 alpha)- 17-(acetyloxy)-19-norpregna-4-en-20-yn-3-one] and 20 mcg ethinyl estradiol [(17 alpha)- 19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol]; each light purple tablet contains 1 mg norethindrone acetate and 30 mcg ethinyl estradiol; and each purple tablet contains 1 mg norethindrone acetate, 35 mcg ethinyl estradiol. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 20 mcg) also contain: Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 30 mcg) also contain: Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine. Norethindrone acetate and ethinyl estradiol tablets (1 mg and 35 mcg) also contain: Lactose anhydrous, lactose monohydrate, povidone K-25, dl-α-tocopherol, magnesium stearate, microcrystalline cellulose, croscarmellose sodium, aluminium lake of FD and C Blue No. 1, aluminium lake of FD and C Blue No. 2, caramine. The structural formulas are as follows: Each brown tablet contains ferrous fumarate, microcrystalline cellulose, lactose monohydrate, polyvinyl pyrrolidone K-90, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. Each norethindrone acetate and ethinyl estradiol tablet and ferrous fumarate tablet blister contains five white to off white tablets, seven light purple tablets, nine purple tablets, and seven brown tablets. These tablets are to be taken in the following order: one white to off white each day for five days, then light purple tablet each day for seven days, followed by one purple tablet each day for nine days, and then one brown tablet each day for seven days. Structural Formula

Norethindrone acetate and ethinyl estradiol tablets, USP 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 tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. 4 brown, round tablets each containing 75 mg ferrous fumarate. Each white active chewable tablet also contains the following inactive ingredients: acacia, confectioner’s sugar, lactose monohydrate, magnesium stearate, microcrystalline cellulose and talc. Each brown placebo tablet contains ferrous fumarate, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, povidone, spearmint flavor and sucralose. The ferrous fumarate tablets do not serve any therapeutic purpose. The molecular 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 molecular 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. chem structure chem structure 2

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, soft gelatin capsules each containing 75 mg ferrous fumarate, USP Each pink active capsule also contains the following inactive ingredients: sesame oil, linoleoyl polyoxylglycerides, DL-α-tocopherol, dehydrated alcohol, gelatin, sorbitol sorbitan solution, glycerin, FD&C Red #40, titanium dioxide and purified water. Each maroon non-hormonal placebo capsule contains ferrous fumarate USP, soybean oil, yellow beeswax, soy lecithin gelatin, sorbitol sorbitan solution, glycerin, FD&C Blue #1, FD&C Red #40, titanium dioxide and purified water. 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 molecular formula of ethinyl estradiol, USP 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 molecular formula of norethindrone acetate, USP is C 22 H 28 O 3 and the structural formula is: Ethinyl Estradiol Structural Formula Norethindrone Acetate Structural Formula