SPL Set ID: d6c0fc76-644e-4301-9672-f432061e3d37
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 are: colloidal silicon dioxide, hypromellose, magnesium stearate, methacrylic acid copolymer Type A [contains poly (methacrylic acid-co-methyl methacrylate) and sodium lauryl sulfate], microcrystalline cellulose, polyacrylate dispersion 40 percent [contains nonoxynol 100 and poly (ethyl acrylate-co-methyl methacrylate)], simethicone emulsion, talc, titanium dioxide and triethyl citrate. The empty hard gelatin capsule shell contains D&C Red 22, FD&C Blue 1, gelatin, sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac. FDA approved dissolution test specifications differ from USP. Structure