SPL Set ID: cbc3e916-09e2-4e6e-9e5e-98375f5e6d41

1 drug(s) with this SPL Set ID

Open DailyMed details

Mycophenolic Acid MYCOPHENOLIC ACID
360 mg Delayed-release
NOVUGEN PHARMA (USA) LLC. FDA Rx Only

Mycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium, USP 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 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 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, corn starch, crospovidone, magnesium stearate, and povidone (K-30). The enteric coating of the tablet consists of ferric oxide yellow, hypromellose phthalate, titanium dioxide, and FD&C blue no. 2 powder (180 mg) or ferric oxide red (360 mg). image description

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