Source: FDA, National Drug Code (US) Revision Year: 2020
XOFLUZA (baloxavir marboxil) is an antiviral PA endonuclease inhibitor. XOFLUZA is supplied as white to light yellow film-coated tablets for oral administration.
The active component of XOFLUZA is baloxavir marboxil. Baloxavir marboxil has a molecular weight of 571.55 and a partition coefficient (log P) of 2.26. It is freely soluble in dimethylsulfoxide, soluble in acetonitrile, slightly soluble in methanol and ethanol and practically insoluble in water.
The chemical name of baloxavir marboxil is ({(12aR)12[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazin-7-yl}oxy)methyl methyl carbonate. The empirical formula of baloxavir marboxil is C27H23F2N3O7S and the chemical structure is shown below.
The inactive ingredients of XOFLUZA are: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, povidone, sodium stearyl fumarate, talc, and titanium dioxide.
| Dosage Forms and Strengths |
|---|
|
XOFLUZA 20 mg Tablets are white to light yellow, oblong shaped film-coated tablets debossed with “772” on one side and “20” on the other side. XOFLUZA 40 mg Tablets are white to light yellow, oblong shaped film-coated tablets debossed with “BXM40” on one side. |
| Drug | Countries | |
|---|---|---|
| XOFLUZA | Austria, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, New Zealand, Poland, Romania, Singapore, Turkey, United States, South Africa |
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