SPL Set ID: d5ebd7fa-c388-4619-8dcb-e862e4ce5285

1 drug(s) with this SPL Set ID

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MINZOYA LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS BISGLYCINATE
LUPIN PHARMACEUTICALS, INC. FDA Rx Only

Minzoya (levonorgestrel and ethinyl estradiol tablets USP and ferrous bisglycinate tablets) provides an oral contraceptive regimen consisting of 21 white to off-white active tablets and 7 blue inactive tablets. 21 white to off-white active tablets each containing 0.1 mg of levonorgestrel, 13-Ethyl-17-hydroxy- 18,19-dinor-17 α-pregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 19-norpregna-1,3,5(10)-tien-20-yne-3,17-diol,(17α), an estrogenic compound 7 blue inactive tablets each containing 36.5 mg ferrous bisglycinate The inactive ingredients present in white to off-white active tablet are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. Each inactive blue tablet contains the following inactive ingredients: ferrous bisglycinate (containing citric acid, glycine and iron), colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C BLUE #2 aluminium lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide. Levonorgestrel has the empirical formula of C 21 H 28 O 2 and the molecular weight of 312.45, and ethinyl estradiol has the empirical formula of C 20 H 24 O 2 and the molecular weight of 296.4. The molecular structures are provided below: Levonorgestrel USP and Ethinyl Estradiol USP

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