RYBELSUS Tablet Ref.[27432] Active ingredients: Semaglutide

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

Product description

RYBELSUS tablets, for oral use, contain semaglutide, a GLP-1 receptor agonist. The peptide backbone is produced by yeast fermentation. The main protraction mechanism of semaglutide is albumin binding, facilitated by modification of position 26 lysine with a hydrophilic spacer and a C18 fatty di-acid. Furthermore, semaglutide is modified in position 8 to provide stabilization against degradation by the enzyme dipeptidyl-peptidase 4 (DPP-4). A minor modification was made in position 34 to ensure the attachment of only one fatty di-acid. The molecular formula is C187H291N45O59 and the molecular weight is 4113.58 g/mol.

Structural formula:

Semaglutide is a white to almost white hygroscopic powder. Each tablet of RYBELSUS contains 3 mg, 7 mg or 14 mg of semaglutide and the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and salcaprozate sodium (SNAC).

Dosage Forms and Strengths

RYBELSUS tablets are available as:

  • 3 mg: white to light yellow, oval shaped debossed with “3” on one side and “novo” on the other side.
  • 7 mg: white to light yellow, oval shaped debossed with “7” on one side and “novo” on the other side.
  • 14 mg: white to light yellow, oval shaped debossed with “14” on one side and “novo” on the other side.
How Supplied

RYBELSUS tablets are available as follows:

Tablet StrengthDescriptionPackage ConfigurationNDC No.
3 mg White to light yellow, oval shaped debossed with “3” on one side and “novo” on the other side Bottle of 30 tablets 0169-4303-30
7 mg White to light yellow, oval shaped debossed with “7” on one side and “novo” on the other side Bottle of 30 tablets 0169-4307-30
14 mg White to light yellow, oval shaped debossed with “14” on one side and “novo” on the other side Bottle of 30 tablets 0169-4314-30

Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark

Drugs

Drug Countries
RYBELSUS Brazil, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States
 
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