SPL Set ID: d1fb3b66-cac9-49cd-a9f8-c4ce960f66e7
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, USP 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 CI and the molecular weight is 360.83; fenofibrate, USP is insoluble in water. The melting point is 79°C to 82°C. Fenofibrate, USP is a white solid which is stable under ordinary conditions. Inactive Ingredients Each 54 mg fenofibrate tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, iron oxide yellow, lactose monohydrate, lecithin, microcrystalline cellulose, polyvinyl alcohol, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide, xanthan gum, and D&C yellow #10 lake. Each 160 mg fenofibrate tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, lecithin, microcrystalline cellulose, polyvinyl alcohol, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, titanium dioxide, and xanthan gum. Fenofibrate tablet meets USP Dissolution Test 3. structure