Source: FDA, National Drug Code (US) Revision Year: 2018
ROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)N[2-(1,6,7,8-tetrahydro-2Hindeno[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C16H21NO2, molecular weight of 259.34, and the following chemical structure:
Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11.
Each ROZEREM tablet includes the following inactive ingredients: lactose monohydrate, starch, hydroxypropyl cellulose, magnesium stearate, hypromellose, copovidone, titanium dioxide, yellow ferric oxide, polyethylene glycol 8000, and ink containing shellac and synthetic iron oxide black.
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ROZEREM is available in an 8 mg strength tablet for oral administration. ROZEREM 8 mg tablets are round, pale orange-yellow, film-coated, with “TAK” and “RAM-8” printed on one side. |
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ROZEREM is available as round, pale orange-yellow, film-coated, 8 mg tablets, with “TAK” and “RAM-8” printed on one side, in the following quantities:
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| Drug | Countries | |
|---|---|---|
| ROZEREM | Brazil, Japan, United States |
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