Necon
Necon® 1/35
(norethindrone and ethinyl estradiol) Tablets USP
Necon® 0.5/35
(norethindrone and ethinyl estradiol) Tablets USP
Necon® 10/11
(norethindrone and ethinyl estradiol) Tablets USP
Necon® 1/50
(norethindrone and mestranol) Tablets USP
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
DRUG DESCRIPTION
Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol:
Necon® 1/35: Each dark yellow tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include D&C Yellow No. 10 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon® 1/35 package contains only inert ingredients, as follows: micro- crystalline cellulose, lactose (anhydrous), and magnesium stearate.
Necon® 0.5/35: Each light yellow tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include D&C Yellow No. 10 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon® 0.5/35 package contains only inert ingredients as listed under white tablets in Necon® 1/35.
Necon® 10/11: Each light yellow tablet (10) contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Each dark yellow tablet (11) contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include D&C Yellow No. 10 Aluminum Lake, microcrys- talline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon® 10/11 package contains only inert ingredients as listed under white tablets in Necon® 1/35.
Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound mestranol:
Necon® 1/50: Each light blue tablet contains 1 mg of norethindrone and 0.05 mg of mestranol. Inactive ingredients include FD&C Blue No. 1 Aluminum Lake, microcrystalline cellulose, lactose (anhydrous), magnesium stearate, polacrilin potassium, and povidone. Each white tablet in the Necon® 1/50 package contains only inert ingredients as listed under white tablets in Necon® 1/35.
The chemical name for norethindrone is 17- hydroxy-19-nor-17a-pregn-4-en-20-yn-3-one, for ethinyl estradiol is 19-nor-17a-pregna- 1,3,5(10)-trien-20-yn-3,17-diol, and for mestranol is 3-methoxy-19-nor-17a-pregna-1,3,5(10)- trien-20-yn-17-ol. The structural formulas are as follows:
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Generic Name: Norethindrone and Ethinyl Estradiol Tablets
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