SPL Set ID: 58503afe-b8d4-4710-a194-e3acd64ecf1f
1 drug(s) with this SPL Set ID
Each mesalamine extended-release capsule, USP is a delayed- and extended-release dosage form for oral administration. Each capsule contains 0.375 g of mesalamine USP (5-aminosalicylic acid, 5-ASA), an aminosalicylate. The structural formula of mesalamine is: Molecular Weight: 153.14 Molecular Formula: C 7 H 7 NO 3 Each mesalamine extended-release capsule, USP contains granules composed of mesalamine in a polymer matrix with an enteric coating that dissolves at pH 6 and above. The inactive ingredients of mesalamine extended-release capsules, USP are: microcrystalline cellulose, ethyl cellulose, hypromellose, methacrylic acid and methyl methacrylate copolymer (1:1), triethyl citrate, talc, gelatin, FD&C Blue 2, titanium dioxide, shellac, potassium hydroxide and black iron oxide. FDA approved dissolution test specifications differ from the USP. Mesalamine Structural Formula