SPL Set ID: a62e2a6a-6235-7580-e053-2a95a90aa2b0
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-HT 3 receptor type. Chemically it is ( ± ) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1 H -imidazol-1-yl) methyl]-4 H -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 1 mL of the preservative-free aqueous solution in the 2-mL single dose vial contains 2 mg of Ondansetron Injection, USP, 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 1 mL of the preserved aqueous solution in the 20-mL multiple dose vial contains 2 mg of Ondansetron Injection, USP, 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. Description1