SPL Set ID: 00dd9b78-dd90-414b-b241-7619aa9d1ed2

1 drug(s) with this SPL Set ID

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Norgestimate and Ethinyl Estradiol NORGESTIMATE AND ETHINYL ESTRADIOL
PD-RX PHARMACEUTICALS, INC. FDA Rx Only

Sprintec ® (norgestimate and ethinyl estradiol tablets USP) is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Each blue tablet contains 0.250 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, lactose monohydrate, magnesium stearate, and pregelatinized corn starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formula is as follows: C 23 H 31 NO 3 M.W. 369.50 C 20 H 24 O 2 M.W. 296.40 2 3

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