Source: FDA, National Drug Code (US) Revision Year: 2020
HYDREA (hydroxyurea capsules, USP) is an antimetabolite available for oral use as capsules containing 500 mg hydroxyurea. Inactive ingredients include citric acid, colorants (D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, and D&C Red No. 28), gelatin, lactose, magnesium stearate, sodium phosphate, and titanium dioxide.
Hydroxyurea is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. The empirical formula is CH4N2O2 and it has a molecular weight of 76.05.
Its structural formula is:
| Dosage Forms and Strengths |
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Capsules: 500 mg opaque green cap and opaque pink body imprinted with “HYDREA” and “830”. |
| How Supplied |
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HYDREA (hydroxyurea capsules, USP) is supplied as 500 mg capsules in HDPE bottles with a plastic safety screw cap. Each bottle contains 100 capsules. The cap is opaque green and the body is opaque pink. The capsules are imprinted on both sections with “HYDREA” and “830” in black ink (NDC 0003-0830-50). Manufactured for: Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA |
| Drug | Countries | |
|---|---|---|
| HYDREA | Australia, Brazil, Canada, Estonia, Spain, Finland, France, Ireland, Japan, Lithuania, Mexico, Netherlands, New Zealand, Romania, Tunisia, Turkey, United Kingdom, United States |
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