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Ortho-Novum - Drug Description

Norethindrone/Ethinyl Estradiol

Saturday, Oct. 20, 2007; 7:17 AM

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 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 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 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, micro-crystalline cellulose and pregelatinized starch.

ORTHO-NOVUM ® 10/ 11 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 starch. Each peach tablet contains 1 mg norethindrone and 0.035 mg ethinyl estradiol. Inactive ingredients include FD& C Yellow No. 6, lactose, magnesium stearate and pregelatinized starch.

Each green tablet contains only inert ingredients, as listed under green tablets in ORTHO-NOVUM 7/ 7/ 7. 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 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 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-17 -pregn-4-en-20-yn-3-one, for ethinyl estradiol is 19-nor-17 -pregna-1,3,5( 10)-trien-20-yne-3,17-diol.

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