Ortho-Novum (Norethindrone and Ethinyl Estradiol) drug description - FDA approved labeling for prescription drugs and medications at RxList

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Ortho-Novum

Drug Description

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ORTHO-NOVUM®
(norethindrone/ethinyl estradiol) Tablets
and
MODICON®
(norethindrone/ethinyl estradiol) Tablets

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

DRUG DESCRIPTION

COMBINATION ORAL CONTRACEPTIVES

Each of the following products is a combination oral contraceptive containing the progestational compound norethindrone and the estrogenic compound ethinyl estradiol.

ORTHO-NOVUM®7/7/7 Tablets: Each white tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include lactose, magnesium stearate and pregelatinized corn starch. Each light peach tablet contains 0.75 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Yellow No. 6, lactose, magnesium stearate and pregelatinized corn starch. Each peach tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Yellow No. 6, lactose, magnesium stearate and pregelatinized corn starch. Each green tablet contains only inert ingredients, as follows: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch.

ORTHO-NOVUM®1/35 Tablets: Each peach tablet contains 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include FD&C Yellow No. 6, lactose, magnesium stearate and pregelatinized corn starch. Each green tablet contains only inert ingredients, as listed under green tablets in ORTHO-NOVUM 7/7/7.

MODICON®Tablets: Each white tablet contains 0.5 mg of norethindrone and 0.035 mg of ethinyl estradiol. Inactive ingredients include lactose, magnesium stearate and pregelatinized corn starch. Each green tablet contains only inert ingredients, as listed under green tablets in ORTHO-NOVUM 7/7/7.

The chemical name for norethindrone is 17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one, for ethinyl estradiol is 19-Nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulas are as follows: