XENICAL Capsule Ref.[10625] Active ingredients: Orlistat

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

Product description

XENICAL (orlistat) is a gastrointestinal lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats.

Orlistat is (S)-2-formylamino-4-methyl-pentanoic acid (S)1[[(2S, 3S)-3-hexyl-4-oxo-2-oxetanyl] methyl]-dodecyl ester. Its empirical formula is C29H53NO5, and its molecular weight is 495.7. It is a single diastereomeric molecule that contains four chiral centers, with a negative optical rotation in ethanol at 529 nm.

The structure is:

Orlistat is a white to off-white crystalline powder. Orlistat is practically insoluble in water, freely soluble in chloroform, and very soluble in methanol and ethanol. Orlistat has no p Ka within the physiological pH range.

XENICAL is available for oral administration as a turquoise hard-gelatin capsule. The capsule is imprinted with black. Each capsule contains a pellet formulation consisting of 120 mg of the active ingredient, orlistat, as well as the inactive ingredients microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, and talc. The capsule shell contains gelatin, titanium dioxide, and FD&C Blue No. 2 with black printing ink containing pharmaceutical grade shellac, propylene glycol, strong ammonium solution, potassium hydroxide and black iron oxide.

Dosage Forms and Strengths

XENICAL 120 mg turquoise capsules imprinted with XENICAL 120 in black ink.

How Supplied

XENICAL is a turquoise, hard-gelatin capsule containing pellets of powder.

XENICAL 120 mg Capsules: Turquoise, two-piece, No. 1 opaque hard-gelatin capsule imprinted with XENICAL 120 in black ink — bottle of 90 (NDC 61269-460-90).

XENICAL is a registered trademark of CHEPLAPHARM Arzneimittel GmbH.

Licensed by: CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Distributed by: H2-Pharma, LLC, 2010 Berry Chase Place, Montgomery, AL 36117, USA

Drugs

Drug Countries
XENICAL Austria, Australia, Canada, Cyprus, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

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