SPL Set ID: 5b224d7f-fecb-4531-9d27-008347777c9d
1 drug(s) with this SPL Set ID
Mycophenolic acid delayed-release tablets USP are an enteric formulation of mycophenolate sodium USP that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid delayed-release tablets USP 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 molecular 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, is a white to off-white crystalline hygroscopic powder and is slightly soluble in water 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 anhydrous lactose, colloidal silicon dioxide, crospovidone, magnesium stearate, povidone and pregelatinized starch (maize). The enteric coating of the tablet consists of colloidal anhydrous silica, iron oxide yellow, methacrylic acid and ethyl acrylate copolymer, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. In addition 180 mg contains FD&C Blue no. 2 aluminium lake and 360 mg contains iron oxide red. The tablets are imprinted with black ink containing black iron oxide, propylene glycol and shellac glaze. The 180 mg and 360 mg mycophenolic acid delayed-release tablets, USP each contain 13.08 mg and 26.15 mg of sodium respectively. Chemical Structure