SPL Set ID: 8b247e46-203e-4f5b-b5a7-cbd57341c735

Each of the following products is a combination oral contraceptive containing the progestational compound norgestimate, USP and the estrogenic compound ethinyl estradiol, USP. Norgestimate, USP is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime,(17α)-(+)-) and ethinyl estradiol, USP is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Norgestimate and Ethinyl Estradiol Tablets, USP 0.25 mg/0.035 mg • Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include lactose monohydrate, povidone, FD&C Blue No. 2, colloidal silicon dioxide, talc, magnesium stearate, and pregelatinized starch. • Each light green tablet contains only inert ingredients, as follows: D&C Yellow No. 10, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. Norgestimate and Ethinyl Estradiol Tablets, USP 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg • Each white to off-white tablet contains 0.18 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include lactose monohydrate, povidone, magnesium stearate, colloidal silicon dioxide, talc and pregelatinized starch. • Each light blue tablet contains 0.215 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include FD & C Blue No. 2, lactose monohydrate, povidone, magnesium stearate, colloidal silicon dioxide, talc and pregelatinized starch. • Each blue tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include FD & C Blue No. 2, lactose monohydrate, povidone, magnesium stearate, colloidal silicon dioxide, talc and pregelatinized starch. • Each light green tablet contains only inert ingredients, as follows: D&C Yellow No. 10, FD&C Blue No. 2, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc. chemstructures