COREG CR Extended-release tablet Ref.[49689] Active ingredients: Carvedilol

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

Product description

Carvedilol phosphate is a nonselective β‑adrenergic blocking agent with α1-blocking activity. It is (2RS) - 1- (9H-Carbazol-4-yloxy) - 3- [[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol phosphate salt (1:1) hemihydrate. It is a racemic mixture with the following structure:

Carvedilol phosphate is a white-to-almost white solid with a molecular weight of 513.5 (406.5 carvedilol free base) and a molecular formula of C24H26N2O4•H3PO4•1/2 H2O.

COREG CR is available for once-a-day administration as controlled-release oral capsules containing 10, 20, 40, or 80 mg carvedilol phosphate. COREG CR hard gelatin capsules are filled with carvedilol phosphate immediate-release and controlled-release microparticles that are drug-layered and then coated with methacrylic acid copolymers. Inactive ingredients include crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone.

Dosage Forms and Strengths

The hard gelatin capsules are filled with white to off-white microparticles and are available in the following strengths:

  • 10 mg – white and green capsule shell printed with “GSLGK” and "10 mg"
  • 20 mg – white and yellow capsule shell printed with “GSMHV” and "20 mg"
  • 40 mg – yellow and green capsule shell printed with “GSETX” and "40 mg"
  • 80 mg – white capsule shell printed with “GSF1L” and "80 mg"
How Supplied

The hard gelatin capsules are available in the following strengths:

  • 10 mg – white and green capsule shell printed with “GSLGK” and "10 mg"
  • 20 mg – white and yellow capsule shell printed with “GSMHV” and "20 mg"
  • 40 mg – yellow and green capsule shell printed with “GSETX” and "40 mg"
  • 80 mg – white capsule shell printed with “GSF1L” and "80 mg"
  • 10 mg bottles of 30: NDC 0007-3383-13
  • 20 mg bottles of 30: NDC 0007-3385-13
  • 40 mg bottles of 30: NDC 0007-3387-13
  • 80 mg bottles of 30: NDC 0007-3388-13

Drugs

Drug Countries
COREG CR United States

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