Source: FDA, National Drug Code (US) Revision Year: 2022
Decitabine is a nucleoside metabolic inhibitor. Decitabine is a white to off-white solid with the molecular formula of C8H12N4O4 and a molecular weight of 228.21 daltons. Its international union of pure and applied chemistry (IUPAC) chemical name is 4-amino-1-[(2R,4S,5R)-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-1,3,5-triazin-2(1H)-one and it has the following structural formula:
Cedazuridine is a cytidine deaminase inhibitor. Cedazuridine is a white to off-white solid with the molecular formula of C9H14F2N2O5 and a molecular weight of 268.21 daltons. Its IUPAC chemical name is (4R)1[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-4-hydroxy-1,3-diazinan-2-one and it has the following structural formula:
INQOVI (decitabine and cedazuridine) tablets, for oral use contain 35 mg decitabine and 100 mg cedazuridine. The tablets are biconvex, oval-shaped, film-coated, red and debossed with “H35” on one side. Each film-coated tablet contains the following inactive ingredients: lactose monohydrate, hypromellose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating material contains polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide red.
| Dosage Forms and Strengths |
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INQOVI tablets contain 35 mg decitabine and 100 mg cedazuridine. The tablets are biconvex, oval-shaped, film-coated, red and debossed with “H35” on one side. |
| How Supplied |
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INQOVI tablets are biconvex, oval-shaped, film-coated, red, and debossed with “H35” on one side. The tablets are packaged in blisters and supplied as follows: NDC: 64842-0727-9; 5 tablets in one blister card in a child-resistant carton Manufactured for: Otsuka Pharmaceutical Co., Ltd., Japan Distributed by: Taiho Oncology, Inc., Princeton, NJ 08540 USA |
| Drug | Countries | |
|---|---|---|
| INQOVI | Canada, United States |
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