SPL Set ID: 620f86cb-b6a2-4af8-a642-925dd8a1c5fe

Each Balsalazide Disodium Capsules, USP contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an aminosalicylate. Each capsule of balsalazide disodium (750 mg) is equivalent to 267 mg of mesalamine. Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate. Its structural formula is: Molecular Weight: 437.32 Molecular Formula: C 17 H 13 N 3 O 6 Na 2 ●2H 2 O Balsalazide disodium is a stable orange to yellow crystalline powder. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol and practically insoluble in all other organic solvents. Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. Additionally, the capsule shell contains gelatin, titanium dioxide, iron oxide yellow, and iron oxide red. The black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and water. The sodium content of each capsule is approximately 78.89 mg/ capsule (10.51%). chemstruc