Source: FDA, National Drug Code (US) Revision Year: 2020
EFUDEX Solutions and Cream are topical preparations containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite.
EFUDEX Solution consists of 2% or 5% fluorouracil on a weight/weight basis, compounded with disodium edetate, hydroxypropyl cellulose, methylparaben, propylene glycol, propylparaben, and tris (hydroxymethyl) aminomethane.
EFUDEX Cream contains 5% fluorouracil in a vanishing cream base consisting of methylparaben, polysorbate 60, propylene glycol, propylparaben, purified water, stearyl alcohol, and white petrolatum.
Chemically, fluorouracil is a 5-fluoro-2,4(1H,3H)-pyrimidinedione. It is a white to practically white crystalline powder which is sparingly soluble in water and slightly soluble in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene glycol.
The molecular weight of 5-fluorouracil is 130.08 and the structural formula is:
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EFUDEX Solution is available in 10 mL drop dispensers containing either 2% (NDC 0187-3202-10) or 5% (NDC 0187-3203-10) fluorouracil and 25 mL drop dispensers containing either 2% (NDC 0187-3202-02) or 5% (NDC 0187-3203-02) fluorouracil on a weight/weight basis compounded with disodium edetate, hydroxypropyl cellulose, methylparaben, propylene glycol, propylparaben, and tris (hydroxymethyl) aminomethane. EFUDEX Cream is available in 40 g tubes containing 5% fluorouracil (NDC 0187-3204-47) in a vanishing cream base consisting of methylparaben, polysorbate 60, propylene glycol, propylparaben, purified water, stearyl alcohol, and white petrolatum. Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA Manufactured by: Mylan Institutional Inc., Sugar Land, TX 77478 USA |
| Drug | Countries | |
|---|---|---|
| EFUDEX | Canada, United States |
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