SPL Set ID: 5c1d0a3a-1b24-44a0-9c53-224365b65945
1 drug(s) with this SPL Set ID
Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP are an extended-cycle oral contraceptive. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets consist of 42 white to off-white tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 light peach tablets containing 0.15 mg levonorgestrel and 0.025 mg ethinyl estradiol, and 21 bluish green tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg ethinyl estradiol. Levonorgestrel is a progestin and ethinyl estradiol is an estrogen. The structural formulas, molecular formulas, molecular weights, and chemical names for the active components are shown below: 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)-. Each white to off-white tablet contains the following inactive ingredients: lactose monohydrate, polacrilin potassium and magnesium stearate. Each light peach tablet contains the following inactive ingredients: lactose monohydrate, polacrilin potassium, FD&C Yellow No. 6 Aluminum Lake and magnesium stearate. Each bluish green tablet contains the following inactive ingredients: lactose monohydrate, polacrilin potassium, D&C Yellow No.10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and magnesium stearate. Each yellow tablet contains the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, polacrilin potassium, D&C Yellow No.10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, lactose monohydrate, povidone K-25 and dl -α-tocopherol. Meets USP Dissolution Test 2 for Ethinyl Estradiol 0.01 mg Structural Formula Structural Formula