SPL Set ID: bc38bc5e-7f0a-4419-81ec-04726ce47421

Mmycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its empirical formula is C 17 H 19 O 6 Na. The molecular weight is 342.32 g/mol and the structural formula is: Mycophenolic acid, USP as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid. Mycophenolic acid is available for oral use as delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include crospovidone, hypromellose, lactose anhydrous, magnesium stearate, povidone, and starch. The enteric coating of the tablet consists of hypromellose phthalate, titanium dioxide, triethyl citrate, ferrosoferric oxide (180 mg), lactose monohydrate (180 mg), propylene glycol (180 mg) and triacetin (180 mg) or polyethylene glycol (360 mg), talc (360 mg), and FD&C yellow # 6 aluminum lake (360 mg). Mycophenolic acid structural formula.