SPL Set ID: 4ef59b85-e5a5-479f-a1fe-e1cee4d87670
1 drug(s) with this SPL Set ID
Each mesalamine capsule 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 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: microcrystalline cellulose, hypromellose, colloidal silicon dioxide, ethyl acrylate and methyl methacrylate 2:1 copolymer, magnesium stearate, methacrylic acid and methyl methacrylate 1:1 copolymer, talc, triethyl citrate, titanium dioxide and hypromellose phthalate. The capsule shell contains titanium dioxide, FD&C Blue 1, FD&C Red 40 and gelatin. The capsule shells are printed with edible black ink containing shellac, black iron oxide and potassium hydroxide. FDA approved dissolution test specifications differ from USP. structure