TRICOR Tablet Ref.[50364] Active ingredients: Fenofibrate

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

TRICOR (fenofibrate tablets), is a lipid regulating agent available as tablets for oral administration. Each tablet contains 48 mg or 145 mg of fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula:

The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79-82°C. Fenofibrate is a white solid which is stable under ordinary conditions.

Inactive Ingredients:

Each tablet contains hypromellose 2910 (3 cps), docusate sodium, sucrose, sodium lauryl sulfate, lactose monohydrate, silicified microcrystalline cellulose, crospovidone, and magnesium stearate.

In addition, individual tablets contain:

48 mg tablets: polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum, D&C Yellow #10 aluminum lake, FD&C Yellow #6 /sunset yellow FCF aluminum lake, FD&C Blue #2 /indigo carmine aluminum lake.

145 mg tablets: polyvinyl alcohol, titanium dioxide, talc, soybean lecithin, xanthan gum.

Dosage Forms and Strengths
  • 48 mg yellow tablets, imprinted with the code identification letters “FI”.
  • 48 mg yellow tablets, imprinted with the “a” logo and code identification letters “FI”.
  • 145 mg white tablets, imprinted with the code identification letters “FO”.
  • 145 mg white tablets, imprinted with the “a” logo and code identification letters “FO”.
How Supplied

TRICOR (fenofibrate tablets) is available in two strengths:

48 mg:

Yellow tablets, imprinted with the code identification letters “FI”, available in bottles of 90 (NDC 0074-3173-90).

Yellow tablets, imprinted with the “a” logo and code identification letters “FI”, available in bottles of 90 (NDC 0074-6122-90).

145 mg:

White tablets, imprinted with the code identification letters “FO”, available in bottles of 90 (NDC 0074-3189-90).

White tablets, imprinted with the “a” logo and code identification letters “FO”, available in bottles of 90 (NDC 0074-6123-90).

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

Drugs

Drug Countries
TRICOR Croatia, Japan, United States, South Africa

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