TRILIPIX Delayed release capsule Ref.[11128] Active ingredients: Fenofibrate

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

Product description

Trilipix (fenofibric acid) is a lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2-hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate (1:1) with the following structural formula:

The empirical formula is C22H28ClNO5 and the molecular weight is 421.91. Choline fenofibrate is freely soluble in water. The melting point is approximately 210°C. Choline fenofibrate is a white to yellow powder, which is stable under ordinary conditions.

Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: hypromellose, povidone, water, hydroxypropyl cellulose, colloidal silicon dioxide, sodium stearyl fumarate, methacrylic acid copolymer, talc, triethyl citrate. The capsule shell of the 45 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, yellow iron oxide, black iron oxide, and red iron oxide. The capsule shell of the 135 mg capsule contains the following inactive ingredients: gelatin, titanium dioxide, yellow iron oxide, and FD&C Blue #2.

Dosage Forms and Strengths
  • 45 mg capsules with a reddish brown to orange brown cap and a yellow body imprinted in black ink the number “45”.
  • 45 mg capsules with a reddish brown to orange brown cap imprinted in white ink the “a” logo and a yellow body imprinted in black ink the number “45”.
  • 135 mg capsules with a blue cap and a yellow body imprinted in black ink the number “135”.
  • 135 mg capsules with a blue cap imprinted in white ink the “a” logo and a yellow body imprinted in black ink the number “135”.
How Supplied

Trilipix (fenofibric acid) delayed release capsules 45 mg:

  • A reddish brown to orange brown cap and a yellow body imprinted in black ink the number “45”, available in bottles of 90 (NDC 0074-3161-90).
  • A reddish brown to orange brown cap imprinted in white ink the “a” logo and a yellow body imprinted in black ink the number “45”, available in bottles of 90 (NDC 0074-9642-90).

Trilipix (fenofibric acid) delayed release capsules 135 mg:

  • A blue cap and a yellow body imprinted in black ink the number “135”, available in bottles of 90 (NDC 0074-3162-90).
  • A blue cap imprinted in white ink the “a” logo and a yellow body imprinted in black ink the number “135”, available in bottles of 90 (NDC 0074-9189-90).

Manufactured for AbbVie Inc., North Chicago, IL 60064, U.S.A. by Fournier Laboratories Ireland Limited, Anngrove, Carrigtwohill Co. Cork, Ireland, or AbbVie LTD, Barceloneta, PR 00617.

Drugs

Drug Countries
TRILIPIX Ecuador, Singapore, United States
 
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