SPL Set ID: b1a1256c-a1eb-4abe-ab1e-30e4711afd16

1 drug(s) with this SPL Set ID

Open DailyMed details

SYMPROIC NALDEMEDINE
BIODELIVERY SCIENCES INTERNATIONAL INC FDA Rx Only

SYMPROIC (naldemedine), an opioid antagonist, contains naldemedine tosylate as the active ingredient. The chemical name for naldemedine tosylate is: 17-(cyclopropylmethyl)-6,7-didehydro-4,5α-epoxy-3,6,14-trihydroxy-N-[2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl]morphinan-7-carboxamide 4-methylbenzenesulfonic acid. The structural formula is: The empirical formula for naldemedine tosylate is C 32 H 34 N 4 O 6 ∙C 7 H 8 O 3 S and the molecular weight is 742.84. Naldemedine tosylate is a white to light tan powder, soluble in dimethylsulfoxide and methanol, slightly soluble in alcohol and water, and independent of pH. SYMPROIC (naldemedine) tablets for oral use contain 0.2 mg naldemedine (equivalent to 0.26 mg of naldemedine tosylate). Excipients are: D-mannitol, croscarmellose sodium, magnesium stearate, hypromellose, talc, and yellow ferric oxide. Chemical Structure

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