BUSULFEX Solution for injection Ref.[11121] Active ingredients: Busulfan

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

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

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

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

Drugs

Drug Countries
BUSULFEX Hong Kong, Israel, Japan, Singapore, United States

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