SPL Set ID: 3f2b3a16-7735-487e-9a2c-e078a18df1bc
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 molecular formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83 g/mol; fenofibrate, USP 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 croscarmellose sodium, NF; hypromellose, USP; magnesium stearate, NF; and microcrystalline cellulose, NF. The film-coating material contains hypromellose, macrogol, polydextrose, titanium dioxide and triacetin. In addition, the 54 mg strength film-coating material also contains D&C Yellow No. 10 Aluminum Lake and FD&C Yellow # 6/Sunset yellow FCF aluminum lake. 1