SPL Set ID: bd51a08e-cd45-4315-9bca-41794450ef16

1 drug(s) with this SPL Set ID

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Tri-VyLibra Lo NORGESTIMATE AND ETHINYL ESTRADIOL
AFAXYS PHARMA, LLC FDA Rx Only

Tri-VyLibra Lo is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Each active white to off white tablet contains 0.180 mg of norgestimate USP and 0.025 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each active pale blue to bluish white tablet contains 0.215 mg of norgestimate USP and 0.025 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each active blue to light blue tablet contains 0.250 mg of norgestimate USP and 0.025 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each green placebo tablet contains only inert ingredients, as follows: anhydrous lactose, FD&C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone. Chemical Structure

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