SPL Set ID: 7e79d495-5d59-485e-b3c2-7c31ba044948
1 drug(s) with this SPL Set ID
Fenofibrate tablets, USP are 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 empirical formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79° to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each 54 mg fenofibrate tablet, USP contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, D&C yellow #10 aluminum lake, FD&C Yellow # 6/Sunset yellow FCF aluminum lake, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, simethicone, sodium benzoate, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide. Each 160 mg fenofibrate tablet, USP contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, simethicone, sodium benzoate, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide. Fenofibrate meets USP Dissolution Test 2. 11