Source: FDA, National Drug Code (US) Revision Year: 2019
CYSTAGON (cysteamine bitartrate) Capsules for oral administration, contain cysteamine bitartrate, a cystine depleting agent which lowers the cystine content of cells in patients with cystinosis, an inherited defect of lysosomal transport. CYSTAGON is the bitartrate salt of cysteamine, an aminothiol, beta-mercaptoethylamine. Cysteamine bitartrate is a highly water soluble white powder with a molecular weight of 227 and the molecular formula C2H7NS • C4H6O6.
It has the following chemical structure:
Each CYSTAGON Capsule contains 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate. CYSTAGON Capsules contain the following inactive ingredients: ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, pregelatinized starch, propylene glycol, sodium lauryl sulfate and titanium dioxide.
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CYSTAGON (cysteamine bitartrate) Capsules are hard gelatin capsules which provide 50 mg or 150 mg of cysteamine free base as cysteamine bitartrate: CYSTAGON Capsules, 50 mg are white, opaque capsules printed with CYSTA 50 on the body and MYLAN on the cap. They are available as follows: NDC 0378-9040-05 CYSTAGON Capsules, 150 mg are white, opaque capsules printed with CYSTAGON 150 on the body and MYLAN on the cap. They are available as follows: NDC 0378-9045-05 |
| Drug | Countries | |
|---|---|---|
| CYSTAGON | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, United Kingdom, United States |
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