VIBERZI Film-coated tablet Ref.[27436] Active ingredients: Eluxadoline

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

Product description

The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist.

The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)1(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid.

Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5.

The chemical structure of eluxadoline is:

VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red).

Dosage Forms and Strengths
  • 75 mg tablets: capsule-shaped tablets are coated in pale-yellow to light tan color debossed with “FX75” on one side. Each tablet contains 75 mg eluxadoline.
  • 100 mg tablets: capsule-shaped tablets are coated in pink-orange to peach color debossed with “FX100” on one side. Each tablet contains 100 mg eluxadoline.
How Supplied

VIBERZI is available as:

75 mg tablets: capsule-shaped tablets, coated in pale-yellow to light tan color, debossed with “FX75” on one side.

Bottle of 60: NDC 61874-075-60

100 mg tablets: capsule-shaped tablets, coated in pink-orange to peach color, debossed with “FX100” on one side.

Bottle of 60: NDC 61874-100-60

Distributed by: Allergan USA, Inc., Madison, NJ 07940

Drugs

Drug Countries
VIBERZI Canada, New Zealand, United States

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