SPL Set ID: 99acfdb5-e782-4933-b739-319dfede8c1d

1 drug(s) with this SPL Set ID

Open DailyMed details

Prucalopride PRUCALOPRIDE
1 mg Tablet
AMNEAL PHARMACEUTICALS NY LLC FDA Rx Only

Prucalopride tablets for oral use contain prucalopride succinate, a dihydrobenzofurancarboxamide that is a serotonin type 4 (5-HT 4 ) receptor agonist. The IUPAC name is: 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydrobenzofuran-7-carboxamide succinate. The molecular formula is C 18 H 26 ClN 3 O 3 .C 4 H 6 O 4 and the molecular weight is 485.96 g/mol. The structural formula is: Prucalopride succinate is a white to almost white powder. It is sparingly soluble in dimethyl sulphoxide, methanol and soluble in water. Each 1 mg film-coated tablet of prucalopride contains 1 mg of prucalopride (equivalent to 1.32 mg prucalopride succinate), and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. The coating for the 1 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, and triacetin. Each 2 mg film-coated tablet of prucalopride contains 2 mg of prucalopride (equivalent to 2.64 mg prucalopride succinate), and the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, and microcrystalline cellulose. The coating for the 2 mg tablet contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, triacetin, red iron oxide, and yellow iron oxide. Structural Formula

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