SPL Set ID: 11616da5-54ae-400c-9acc-6efc729f6a17
1 drug(s) with this SPL Set ID
Fenofibrate is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula: The molecular formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients: Each tablet contains betadex, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, docusate sodium with sodium benzoate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate (potato) and titanium dioxide. In addition, the 54 mg individual tablets contain D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Meets USP Dissolution Test 3.