SPL Set ID: 8516e135-5cc0-ef2d-6dad-0f9f841bb27b
1 drug(s) with this SPL Set ID
Mycophenolic acid delayed-release tablets, USP are 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, as the sodium salt (mycophenolate sodium, USP), 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 colloidal silicon dioxide, crospovidone, lactose anhydrous, magnesium stearate, maize starch and povidone (K-30). The enteric coating of the tablet consists of FD & C Blue No. 2 Aluminum Lake (180 mg), ferric oxide red (360 mg), ferric oxide yellow, hypromellose phthalate and titanium dioxide. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). Chemical Structure