SPL Set ID: b7b8ae08-3fb0-4c6c-af02-89f0f6f40ffb

1 drug(s) with this SPL Set ID

Open DailyMed details

SETLAKIN LEVONORGESTREL AND ETHINYL ESTRADIOL
NORTHSTAR RX LLC FDA Rx Only

SETLAKIN (levonorgestrel and ethinyl estradiol tablets) is an extended-cycle combination oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 white inert tablets (without hormones). 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)-. Each pink active tablet (84) contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, talc, macrogol/polyethylene glycol 3350 NF, lecithin (soya), FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, and FD&C Yellow #6 Aluminum Lake, lactose, magnesium stearate, pregelatinized corn starch and microcrystalline cellulose. Each white inert tablet (7) contains the following inactive ingredients: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol 8000, lactose, magnesium stearate and pregelatinized corn starch. levonorgestrel ethinyl estradiol

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