SPL Set ID: bb4bc810-db26-471b-9ce7-6e2fb3018af0
1 drug(s) with this SPL Set ID
The active ingredient of Ondansetron Injection, USP is ondansetron hydrochloride, a selective blocking agent of the serotonin 5-HT 3 receptor type. Its chemical name 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: The empirical formula is C 18 H 19 N 3 O•HCl•2H 2 O, representing a molecular weight of 365.9. Ondansetron HCl is a white to off-white powder that is soluble in water and normal saline. Each 1 mL of aqueous solution in the 2 mL single-dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 9 mg of Sodium Chloride, USP; and 0.5 mg of Citric Acid Monohydrate, USP and 0.25 mg of Sodium Citrate Dihydrate, USP as buffers in Water for Injection, USP. Each 1 mL of aqueous solution in the 20 mL multiple dose vial contains 2 mg of ondansetron as the hydrochloride dihydrate; 8.3 mg of Sodium Chloride, USP; 0.5 mg of Citric Acid Monohydrate, USP and 0.25 mg of Sodium Citrate Dihydrate, USP as buffers; and 1.2 mg of Methylparaben, NF and 0.15 mg of Propylparaben, NF as preservatives in Water for Injection, USP. Ondansetron Injection, USP is a clear, colorless, nonpyrogenic, sterile solution for intravenous or intramuscular use. The pH of the injection solution is 3.3 to 4.0. Structural formula