Source: FDA, National Drug Code (US) Revision Year: 2020
ZOLINZA contains vorinostat, which is described chemically as N-hydroxy-N'-phenyloctanediamide.
The empirical formula is C14H20N2O3.
The molecular weight is 264.32 and the structural formula is:
Vorinostat is a white to light orange powder. It is very slightly soluble in water, slightly soluble in ethanol, isopropanol and acetone, freely soluble in dimethyl sulfoxide and insoluble in methylene chloride. It has no chiral centers and is non-hygroscopic. The differential scanning calorimetry ranged from 161.7 (endotherm) to 163.9°C. The pH of saturated water solutions of vorinostat drug substance was 6.6. The pKa of vorinostat was determined to be 9.2.
Each 100 mg ZOLINZA capsule for oral administration contains 100 mg vorinostat and the following inactive ingredients: microcrystalline cellulose, sodium croscarmellose and magnesium stearate. The capsule shell excipients are titanium dioxide, gelatin and sodium lauryl sulfate.
| Dosage Forms and Strengths |
|---|
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Capsules: 100 mg white, opaque, hard gelatin capsules with “568” over “100 mg” printed within radial bar in black ink on the capsule body. |
| How Supplied |
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ZOLINZA capsules, 100 mg, are white, opaque hard gelatin capsules with “568” over “100 mg” printed within the radial bar in black ink on the capsule body. They are supplied as follows: NDC 0006-0568-40. Each bottle contains 120 capsules. Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA Manufactured by: Patheon, Inc., Mississauga, Ontario, Canada L5N 7K9 |
| Drug | Countries | |
|---|---|---|
| ZOLINZA | Australia, Canada, Japan, Mexico, United States |
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