Source: FDA, National Drug Code (US) Revision Year: 2023
BRENZAVVY tablets for oral use contain bexagliflozin, an SGLT2 inhibitor.
The chemical name of bexagliflozin is (2S,3R,4R,5S,6R)2(4-chloro-3-(4-(2-cyclopropoxyethoxy)benzyl)phenyl)6(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol.
The molecular formula is C24H29ClO7 and the molecular weight is 464.94 g/mol.
The structural formula is:
Bexagliflozin is a white/off-white to pale yellow powder. It is very slightly soluble in water and freely soluble in methanol, acetone, ethylene glycol, and propylene glycol. It is slightly soluble in heptane, cyclohexane, and toluene. Crystalline bexagliflozin is not hygroscopic.
Each film-coated tablet contains 20 mg of bexagliflozin and the inactive ingredients colloidal silicon dioxide, glyceryl dibehenate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene oxide, and poloxamer 188. In addition, the film coating ingredient, Opadry II Blue 85F99153, contains the inactive ingredients FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, macrogol 3350, partially hydrolyzed polyvinyl alcohol, talc, and titanium dioxide.
| Dosage Forms and Strengths |
|---|
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Tablets: 20 mg, blue, caplet-shaped, biconvex, bevel-edged, debossed with “2” and inverted “2” on one side. |
| How Supplied |
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BRENZAVVY 20 mg tablets are blue, caplet-shaped, biconvex, bevel-edged, film-coated debossed with “2” and inverted “2” on one side. Bottles of 30 tablets – NDC 82381-2174-1 Bottles of 90 tablets – NDC 82381-2174-2 Distributed by: TheracosBio, LLC, 225 Cedar Hill Street, Suite 200, Marlborough, MA 01752 USA |
| Drug | Countries | |
|---|---|---|
| BRENZAVVY | United States |
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