MOVANTIK Film-coated tablet Ref.[10882] Active ingredients: Naloxegol

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

Product description

MOVANTIK (naloxegol), an opioid antagonist, contains naloxegol oxalate as the active ingredient. (Naloxegol is a PEGylated derivative of naloxone.)

The chemical name for naloxegol oxalate is: (5α,6α)-17-allyl-6-(2,5,8,11,14,17,20-heptaoxadocosan-22-yloxy)-4,5-epoxymorphinan-3,14-diol oxalate.

The structural formula is:

The empirical formula for naloxegol oxalate is C34H53NO11.C2H2O4 and the molecular weight is 742.

Naloxegol oxalate is a white to off-white powder, with high aqueous solubility across the physiologic pH range.

MOVANTIK (naloxegol) tablets for oral use contain 14.2 mg and 28.5 mg of naloxegol oxalate, respectively, equivalent to 12.5 mg and 25 mg of naloxegol.

Excipients in tablet core are: mannitol, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, and propyl gallate.

Excipients in tablet coat are: hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide black.

Dosage Forms and Strengths

MOVANTIK (naloxegol) is available in two strengths:

  • Tablets: 12.5 mg supplied as mauve, oval, biconvex, film-coated, intagliated with “nGL” on one side and “12.5” on the other side.
  • Tablets: 25 mg supplied as mauve, oval, biconvex, film-coated, intagliated with “nGL” on one side and “25” on the other side.
How Supplied

MOVANTIK (naloxegol) tablets are supplied as:

  • NDC 57841-1300-1: 12.5 mg, bottle of 30 tablets
  • NDC 57841-1300-2: 12.5 mg, bottle of 90 tablets
  • NDC 57841-1300-3: 12.5 mg, unit dose blister carton of 100 tablets (for HUD only)
  • NDC 57841-1301-1: 25 mg, bottle of 30 tablets
  • NDC 57841-1301-2: 25 mg, bottle of 90 tablets
  • NDC 57841-1301-3: 25 mg, unit dose blister carton of 100 tablets (for HUD only)

MOVANTIK is a registered trademark of the AstraZeneca Group of companies and used under license by RedHill Biopharma Inc.

Distributed by: RedHill Biopharma Inc., Raleigh, NC 27617

Drugs

Drug Countries
MOVANTIK Canada, New Zealand, United States
 
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