RINVOQ Extended-release tablet Ref.[10384] Active ingredients: Upadacitinib

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

Product description

RINVOQ is formulated with upadacitinib, a JAK inhibitor.

Upadacitinib has the following chemical name: (3S,4R)-3-Ethyl-4-(3Himidazo[1,2a]pyrrolo[2,3-e]pyrazin-8-yl)N(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide hydrate (2:1).

The strength of upadacitinib is based on anhydrous upadacitinib. The solubility of upadacitinib in water is 38 to less than 0.2 mg/mL across a pH range of 2 to 9 at 37 oC.

Upadacitinib has a molecular weight of 389.38 g/mol and a molecular formula of C17H19F3N6O • ½ H2O.

The chemical structure of upadacitinib is:

RINVOQ 15 mg extended-release tablets for oral administration are purple, biconvex oblong, with dimensions of 14 × 8 mm, and debossed with ‘a15’ on one side.

Each tablet contains the following inactive ingredients: microcrystalline cellulose, hypromellose, mannitol, tartaric acid, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, ferrosoferric oxide, and iron oxide red.

Dosage Forms and Strengths

RINVOQ 15 mg extended-release tablets for oral administration are purple, biconvex oblong, with dimensions of 14 × 8 mm, and debossed with ‘a15’ on one side.

How Supplied

RINVOQ 15 mg extended-release tablets for oral administration are purple, biconvex oblong, with dimensions of 14 × 8 mm, and debossed with ‘a15’ on one side.

30 tablets in a bottle; NDC: 0074-2306-30

Drugs

Drug Countries
RINVOQ Austria, Australia, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa

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