SPL Set ID: 46bbdf70-2b80-4359-a19b-d94ff99eac98

Tri Femynor™ (norgestimate and ethinyl estradiol tablets, USP) is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. 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). Each light pink “active” tablet contains 0.18 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide. Each light red “active” tablet contains 0.215 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide. Each red “active” tablet contains 0.25 mg of norgestimate, USP and 0.035 mg of ethinyl estradiol, USP. Inactive ingredients include croscarmellose sodium, ferric oxide red, hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, talc, and titanium dioxide. Each white placebo tablet contains only inert ingredients, as follows: hydrogenated cottonseed oil, hydroxypropylcellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, talc and titanium dioxide. norgestimate chem struc EE chem struc