Source: FDA, National Drug Code (US) Revision Year: 2021
Methadone hydrochloride tablets for oral suspension contain methadone, an opioid agonist, available as 40 mg dispersible tablets for oral administration. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone 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 tablets for oral suspension 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 molecular formula is C21H27NO•HCl and its structural formula is:
Each METHADOSE Dispersible Tablet (methadone hydrochloride tablets for oral suspension USP) contains 40 mg of methadone hydrochloride USP and the following inactive ingredients: dibasic calcium phosphate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, pregelatinized starch, stearic acid.
Each Methadone Hydrochloride Tablet (methadone hydrochloride tablets for oral suspension USP) (dispersible, orange flavored) contains 40 mg of methadone hydrochloride USP and the following inactive ingredients: colloidal silicon dioxide; monobasic potassium phosphate; magnesium stearate; microcrystalline cellulose; pregelatinized starch; stearic acid; orange blend: FD&C yellow #6, FD&C yellow #6 lake, and FD&C yellow #5 lake; orange flavor.
Methadone hydrochloride tablets for oral suspension are cross-scored, allowing for flexible dosage adjustment. Each tablet may be broken or cut in half to yield two 20-mg doses, or in quarters to yield four 10-mg doses.
Methadone hydrochloride tablets for oral suspension are for oral administration following dispersion in a liquid.
Methadone hydrochloride tablets for oral suspension contain insoluble excipients and must not be injected.
| Dosage Forms and Strengths |
|---|
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METHADOSE Dispersible Tablet for oral administration following dispersion in a liquid: 40 mg of methadone hydrochloride and is a white, round, cross-scored dispersible tablet. Methadone Hydrochloride Tablets (dispersible, orange flavored) for oral administration following dispersion in a liquid: 40 mg of methadone hydrochloride and is an orange, rectangular, cross-scored dispersible tablet. |
| How Supplied |
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METHADOSE Dispersible Tablets, 40 mg: Available as a white, round tablet, debossed with “METHADOSE 40” on one side, a quadrisect on the other. Bottles of 100 NDC 0406-0540-34. Methadone Hydrochloride Tablets for Oral Suspension, USP (Dispersible, Orange Flavored), 40 mg: Available as a speckled orange colored, rounded rectangular tablet, debossed with “M” over “2540” on one side, a quadrisect on the other with an orange odor. Bottles of 100 NDC 0406-2540-01. Methadone hydrochloride tablets for oral suspension, if dispensed, must be packaged in child-resistant containers. SpecGx LLC, Webster Groves, MO 63119 USA |
| Drug | Countries | |
|---|---|---|
| METHADOSE | Canada, United Kingdom, United States |
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