Drug Information for WATSON PHARMARevised: June 2005IN-5260/SPHYSICIAN LABELING Brevicon (Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg) Norinyl 1+35 (Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/0.035 mg) Norinyl 1+50 (Norethindrone and Mestranol Tablets USP, 1 mg/0.05 mg) Rx Only (Watson Pharma, Inc.): DESCRIPTION

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  • Brevicon® Tablets provide a continuous oral contraceptive regimen consisting of 21 blue tablets containing norethindrone 0.5 mg and ethinyl estradiol 0.035 mg and 7 orange tablets containing inert ingredients.

    Norinyl®1+35 Tablets provide a continuous oral contraceptive regimen consisting of 21 yellow-green tablets containing norethindrone 1 mg and ethinyl estradiol 0.035 mg and 7 orange tablets containing inert ingredients.

    Norinyl®1+50 Tablets provide a continuous oral contraceptive regimen consisting of 21 white tablets containing norethindrone 1 mg and mestranol 0.05 mg and 7 orange tablets containing inert ingredients.

    Norethindrone is a potent progestational agent with the chemical name 17-Hydroxy-19-Nor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen with the chemical name 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Mestranol is an estrogen with the chemical name 3-Methoxy-19-nor-17α-pregna-1,3,5(10)-trien-20-yn-17-ol. Their structural formulae follow:

    The blue BREVICON tablets contain the following inactive ingredients: FD&C Blue No. 1, lactose, magnesium stearate, povidone, and starch.

    The yellow-green NORINYL 1+35 tablets contain the following inactive ingredients: D&C Green No. 5, D&C Yellow No. 10, lactose, magnesium stearate, povidone, and starch.

    The white NORINYL 1+50 tablets contain the following inactive ingredients: lactose, magnesium stearate, povidone, and starch.

    The inactive orange tablets in the 28-day regimens of BREVICON, NORINYL 1+35 and NORINYL 1+50 contain the following ingredients: FD&C Yellow No. 6, lactose, microcrystalline cellulose, and magnesium stearate.

  • Drug Information Provided by National Library of Medicine (NLM).
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