SPL Set ID: 1183b048-16f3-47a4-a42f-22ba07b2bb52

1 drug(s) with this SPL Set ID

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Blisovi 24 Fe NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC. FDA Rx Only

Blisovi 24 Fe is a combination oral contraceptive for oral administration consisting of active tablets containing norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, and placebo tablets containing ferrous fumarate, which serve no therapeutic purpose. Each active white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Inactive ingredients include acacia, confectioner's sugar, corn starch, lactose monohydrate, magnesium stearate and talc. Each placebo brown tablet contains 75 mg ferrous fumarate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and sucrose. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution. The chemical name of ethinyl estradiol is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. The empirical formula of ethinyl estradiol is C 20 H 24 O 2 and the structural formula is: The chemical name of norethindrone acetate is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate. The empirical formula of norethindrone acetate is C 22 H 28 O 3 and the structural formula is: "FDA approved dissolution test specifications differ from USP" image-1 image-2

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