SPL Set ID: cd8493f7-91fd-4c2d-b3d7-c1301825586b
1 drug(s) with this SPL Set ID
Each mesalamine capsule is a delayed- and extended-release dosage form for oral administration. Each extended-release 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 extended-release capsule contains pellets 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: ethyl cellulose, hypromellose, methacrylic acid copolymer, starch (source: maize), sucrose, talc and triethyl citrate. The capsule shell contains FD&C blue #1, gelatin, purified water, sodium lauryl sulfate and titanium dioxide. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP. Image