SPL Set ID: 993cd1d7-70a1-a431-e053-2a95a90a5771
1 drug(s) with this SPL Set ID
The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride dihydrate. It has the following structural formula: Ondansetron is a white to off-white powder that is sparingly soluble in water. Each mL of the preservative-free aqueous solution in the 2 mL single use vial contains 2 mg of ondansetron as the hydrochloride; 9 mg of sodium chloride; and 0.5 mg of citric acid monohydrate and 0.25 mg of sodium citrate dihydrate as buffers in water for injection. Each mL of the preserved aqueous solution in the 20 mL multiple dose vial contains 2 mg of ondansetron as the hydrochloride; 8.3 mg of sodium chloride; 0.5 mg of citric acid monohydrate and 0.25 mg of sodium citrate dihydrate as buffers; and 1.2 mg of methylparaben and 0.15 mg of propylparaben as preservatives in water for injection. Ondansetron Injection is a clear, colorless, nonpyrogenic, sterile solution for intravenous use. The pH of the injection solution is 3.3 to 4.0. STRUCTURE