SPL Set ID: ada28708-ab65-4c07-a695-9141c5ce26bc

1 drug(s) with this SPL Set ID

Open DailyMed details

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
MYLAN PHARMACEUTICALS INC. FDA Rx Only

Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP are an extended-cycle an oral contraceptive regimen of 84 white to off-white tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, followed by 7 light peach tablets each containing 0.01 mg ethinyl estradiol. The structural formulas for the active components are: Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-. Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-. Inactive ingredients for the white to off-white tablets include lactose monohydrate, magnesium stearate and polacrilin potassium. Inactive ingredients for the light peach tablets include anhydrous lactose, dl -α-tocopherol, FD&C Yellow No. 6 (Sunset Yellow) Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone k-25 and polacrilin potassium. Meets USP Dissolution Test 2 for Ethinyl Estradiol 0.01 mg Structure Structure

← Back to search