Source: FDA, National Drug Code (US) Revision Year: 2020
FIBRICOR is a lipid regulating agent available as tablets for oral administration. Each tablet contains 35 mg or 105 mg of fenofibric acid. The chemical name for fenofibric acid is 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid with the following structural formula:
Fenofibric acid is a white to almost white crystalline powder that is stable under ordinary conditions, and has a melting point of 179–183°C. Its empirical formula is C17H15ClO4 and molecular weight 318.75. Fenofibric acid is insoluble in water; its solubility increases with pH in buffered media.
Inactive Ingredients: Each tablet contains copovidone, crospovidone, magnesium stearate and microcrystalline cellulose.
| Dosage Forms and Strengths |
|---|
|
35-mg: White, round tablets. Debossed “AR 787”. 105-mg: White, modified oval tablets. Debossed “AR 788”. |
| How Supplied | ||||
|---|---|---|---|---|
|
FIBRICOR (fenofibric acid) Tablets 35 mg, are white, round tablets, debossed “AR 787” on one side and blank on the other side.
FIBRICOR (fenofibric acid) Tablets 105 mg, are white, modified oval tablets, debossed “AR 788” on one side and blank on the other side.
Manufactured for: Athena Bioscience LLC, Athens, GA 30601 |
| Drug | Countries | |
|---|---|---|
| FIBRICOR | United States |
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