UBRELVY Tablet Ref.[10378] Active ingredients:

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

Product description

The active ingredient of UBRELVY is ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of ubrogepant is (3'S)N((3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'pyrrolo[2,3b]pyridine]-3-carboxamide and has the following structural formula:

The molecular formula is C29H26F3N5O3 and molecular weight is 549.6. Ubrogepant is a white to off-white powder. It is freely soluble in ethanol, methanol, acetone, and acetonitrile; and is practically insoluble in water.

UBRELVY is available as tablets for oral administration containing 50 mg or 100 mg ubrogepant. The inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, mannitol, microcrystalline cellulose, polyvinylpyrrolidone vinyl acetate copolymer, sodium chloride, sodium stearyl fumarate, and vitamin E polyethylene glycol succinate.

Dosage Forms and Strengths

UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one side.

UBRELVY 100 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U100” on one side.
How Supplied

UBRELVY 50 mg is supplied as white to off-white, capsule-shaped, biconvex tablets debossed with “U50” on one side in unit-dose packets (each packet contains 1 tablet):

  • Box of 6 Packets, NDC: 0023-6498-06
  • Box of 8 Packets, NDC: 0023-6498-08
  • Box of 10 Packets, NDC: 0023-6498-10
  • Box of 12 Packets, NDC: 0023-6498-12
  • Box of 16 Packets, NDC: 0023-6498-16
  • Box of 30 Packets, NDC: 0023-6498-30

UBRELVY 100 mg is supplied as white to off-white capsule-shaped, biconvex tablets debossed with “U100” on one side in unit-dose packets (each packet contains 1 tablet):

  • Box of 6 Packets, NDC: 0023-6501-06
  • Box of 8 Packets, NDC: 0023-6501-08
  • Box of 10 Packets, NDC: 0023-6501-10
  • Box of 12 Packets, NDC: 0023-6501-12
  • Box of 16 Packets, NDC: 0023-6501-16
  • Box of 30 Packets, NDC: 0023-6501-30

Drugs

Drug Countries
UBRELVY Israel, United States
 
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