SPL Set ID: 5c579378-e00e-4802-b9d3-c062cf8bd9f4
1 drug(s) with this SPL Set ID
Fenofibrate, USP is a peroxisome proliferator-activated receptor (PPAR) alpha agonist available as tablets for oral administration. Each tablet contains 48 mg or 145 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 Cl and the molecular weight is 360.80; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients Each tablet contains colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, silicified microcrystalline cellulose, simethicone, sodium lauryl sulfate and sucrose. In addition, individual tablets contain: 48 mg tablets Iron oxide red, iron oxide yellow, lecithin, polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. 145 mg tablets Lecithin, polyethylene glycol 400, polyethylene glycol 8000, polyvinyl alcohol, talc, titanium dioxide and xanthan gum. FDA approved dissolution test specifications differ from USP. structure