SPL Set ID: 4a159dcd-8af4-4e59-8f46-7b0fe5c22807

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. Structures