CESAMET Capsule Ref.[10771] Active ingredients: Nabilone

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Cesamet (nabilone) is a synthetic cannabinoid for oral administration. Nabilone as a raw material occurs as a white to off-white polymorphic crystalline powder. In aqueous media, the solubility of nabilone is less than 0.5 mg/L, with pH values ranging from 1.2 to 7.0.

Chemically, nabilone is similar to the active ingredient found in naturally occurring Cannabis sativa L. [Marijuana; delta-9-tetrahydrocannabinol (delta-9-THC)]. Nabilone is (±)-trans3(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6-6-dimethyl-9H-dibenzo[b,d]pyran-9-one and has the empirical formula C24H36O3. It has a molecular weight of 372.55.

The structural formula is as follows:

Each 1 mg Cesamet capsule contains 1 mg of nabilone and the following inactive ingredients: povidone and corn starch. The capsule shells contain the following inactive ingredients: FD&C Blue No. 2 (indigo carmine), red iron oxide, gelatin, and titanium dioxide.

How Supplied

Cesamet capsules (blue and white): 1 mg (bottles of 50 capsules) NDC 0187-1231-50. Capsules are imprinted with MEDA on the blue cap and a four-digit code (1221) on the white body.

Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada

Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

Drugs

Drug Countries
CESAMET Canada, Mexico, United States

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