VOCABRIA Film-coated tablet Ref.[10736] Active ingredients: Cabotegravir

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

Product description

VOCABRIA contains cabotegravir, as cabotegravir sodium, an HIV integrase strand transfer inhibitor (INSTI). The chemical name of cabotegravir sodium is sodium (3S,11aR)N[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido [1,2-d]pyrazine-8-carboxamide. The empirical formula is C19H16F2N3NaO5 and the molecular weight is 427.34 g/mol.

It has the following structural formula:

Cabotegravir sodium is a white to almost white crystalline solid that is slightly soluble in water.

Each immediate-release film-coated tablet of VOCABRIA for oral administration contains 30 mg of cabotegravir (equivalent to 31.62 mg cabotegravir sodium) and the inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating contains hypromellose, polyethylene glycol, and titanium dioxide.

Dosage Forms and Strengths

VOCABRIA tablets are white, film-coated, oval tablets debossed with “SV CTV” on one side. Each film-coated tablet contains 30 mg of cabotegravir (equivalent to 31.62 mg cabotegravir sodium).

How Supplied

Each VOCABRIA tablet contains 30 mg of cabotegravir and is a white, oval, film-coated, biconvex tablet debossed with “SV CTV” on one side.

Bottle of 30 tablets with child-resistant closure NDC 49702-248-13.

Manufactured

for: ViiV Healthcare, Research Triangle Park, NC 27709

by: GlaxoSmithKline, Research Triangle Park, NC 27709

Drugs

Drug Countries
VOCABRIA Austria, Canada, Estonia, Finland, Ireland, Israel, Japan, Lithuania, Poland, Romania, United States

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