Source: FDA, National Drug Code (US) Revision Year: 2021
Vibegron is a selective beta-3 adrenergic agonist. The chemical name is (6S)N[4-[[(2S,5R)5[(R)-hydroxy(phenyl)methyl]pyrrolidin-2-yl]methyl]phenyl]-4-oxo-7,8-dihydro-6H-pyrrolo[1,2-a]pyrimidine-6-carboxamide having a molecular formula of C26H28N4O3 and a molecular weight of 444.538 g/mol.
The structural formula of vibegron is:
Vibegron is a crystalline, white to off-white to tan powder.
GEMTESA tablets, for oral administration contain 75 mg of vibegron and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, and microcrystalline cellulose. The light green film coating contains FD&C Blue No. 2 – aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, titanium dioxide, and triacetin.
| Dosage Forms and Strengths |
|---|
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Tablets: 75 mg, oval, light green, film-coated, debossed with V75 on one side and no debossing on the other side. |
| How Supplied |
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GEMTESA 75 mg tablets are light green, oval, film-coated tablets, debossed with V75 on one side and no debossing on the other side. GEMTESA is marketed in two packaging configurations: Thirty (30) tablets in a 60 cc HDPE bottle with a child-resistant cap, NDC 73336-075-30 Ninety (90) tablets in a 60 cc HDPE bottle with a child-resistant cap, NDC 73336-075-90 Manufactured for and Distributed by: Urovant Sciences, Inc., Irvine, CA 92617 |
| Drug | Countries | |
|---|---|---|
| GEMTESA | United States |
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