ROZEREM Film-coated tablet Ref.[10180] Active ingredients: Ramelteon

Source: FDA, National Drug Code (US)  Revision Year: 2018 

Product description

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.

Dosage Forms and Strengths

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.

How Supplied

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:

NDC 64764-805-30 Bottles of 30
NDC 64764-805-10 Bottles of 100
NDC 64764-805-50 Bottles of 500

Drugs

Drug Countries
ROZEREM Brazil, Japan, United States

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