Source: FDA, National Drug Code (US) Revision Year: 2020
Busulfan is a bifunctional alkylating agent known chemically as 1,4-butanediol, dimethanesulfonate. The molecular formula of busulfan is CH3SO2O(CH2)4OSO2CH3 with a molecular weight of 246 g/mole.
Busulfan has the following chemical structure:
BUSULFEX (busulfan) Injection is supplied as a clear, colorless, sterile, solution in 10 mL single-dose vials for intravenous administration upon dilution. Each vial contains 60 mg of busulfan in N,N-dimethylacetamide (DMA), 3.3 mL and Polyethylene Glycol 400, NF 6.7 mL. The solubility of busulfan in water is 0.1 g per L and the pH of BUSULFEX diluted to approximately 0.5 mg per mL busulfan in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP as recommended for infusion reflects the pH of the diluent used and ranges from 3.4 to 3.9.
| Dosage Forms and Strengths |
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Injection: 60 mg/10 mL (6 mg/mL) as a clear, colorless, sterile, solution in a single-dose vial for intravenous use only. |
| How Supplied |
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BUSULFEX is packaged as a sterile solution in 10 mL Single-dose clear glass vials, NDC 59148-070-90. BUSULFEX is distributed as a unit carton of eight vials NDC 59148-070-91. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc., Rockville, MD 20850 Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834 Or Baxter Oncology GmbH, 33790 Halle, Westfalen, Germany |
| Drug | Countries | |
|---|---|---|
| BUSULFEX | Hong Kong, Israel, Japan, Singapore, United States |
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