Low-Ogestrel®Tablets (norgestrel and ethinyl estradiol tablets USP, 0.3
mg/0.03 mg) provide an oral contraceptive regimen consisting of 21 white tablets
followed by 7 peach tablets. Each white tablet, for oral administration contains 0.3 mg of norgestrel and
0.03 mg ethinyl estradiol and the following inactive ingredients: croscarmellose
sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each inactive peach tablet, for oral administration, in the 28 day regimen
contains the following inactive ingredients: anhydrous lactose, FD&C Yellow
No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Norgestrel is a totally s ynthetic progestogen, insoluble in water, freely
soluble in chloroform, sparingly soluble in alcohol with the chemical name (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one.
Ethinyl estradiol is an estrogen, insoluble in water, soluble in alcohol, in
chloroform, in ether, in vegetable oils, and in solutions of fixed alkali hydroxides
with the chemical name 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol.
Their structural formulae follow: