SPL Set ID: c9d7152d-b117-4346-b60c-dc87b59ead09

1 drug(s) with this SPL Set ID

Open DailyMed details

Prucalopride PRUCALOPRIDE
1 mg Tablet
AJANTA PHARMA USA INC. 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-dihydro-1-benzofuran-7-carboxamide succinate. The molecular formula is C 22 H 32 CIN 3 O 7 and the molecular weight is 485.96. The structural formula is: Prucalopride succinate is a white to almost white powder. It is soluble in dimethylacetamide, dimethyl formamide and sparingly soluble in methanol. 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: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. The coating for the 1-mg tablet contains Opadry II 33G28707 White which contains hypromellose, titanium dioxide, lactose monohydrate, macrogol 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: microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide and magnesium stearate. The coating for the 2-mg tablet contains Opadry II 33G34847 Pink which contains hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin, iron oxide red, FD & C Blue #2/ indigo carmine aluminium lake and iron oxide yellow. structure

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