SPL Set ID: 14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab58

1 drug(s) with this SPL Set ID

Open DailyMed details

Methadone Hydrochloride METHADONE HYDROCHLORIDE
SPECGX LLC FDA Rx Only

Methadone hydrochloride oral concentrate USP contains methadone, an opioid agonist, and is available as a red, raspberry flavored liquid concentrate for oral administration. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptone hydrochloride. Methadone hydrochloride, USP is a fine white powder. It is very soluble in water, soluble in isopropanol and in chloroform, and practically insoluble in ether and in glycerine. It is present in methadone hydrochloride oral concentrate as the racemic mixture. Methadone hydrochloride has a melting point of 235°C, a pKa of 8.25 in water at 20°C, a solution (1 part per 100) pH between 4.5 and 6.5, a partition coefficient of 117 at pH 7.4 in octanol/water and a molecular weight of 345.91. Its structural formula is C 21 H 27 NO•HCl. Each liquid concentrate contains 10 mg of methadone hydrochloride (equivalent to 8.95 mg of methadone) per mL and the following inactive ingredients: artificial raspberry flavor, citric acid anhydrous, FD&C Red No. 40, D&C Red No. 33, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution and sucrose. The sodium citrate used to adjust the pH is the dihydrate. Methadone Structure

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