Ondansetron Injection
Product Images NDC 0404-9930

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 0404-9930). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Henry Schein, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Chemical structure of ondansetron hydrochloride dihydrate, showing the molecular arrangement including indole and imidazole rings with associated hydrochloride and water molecules.*

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A table titled 'Recommended Dose and Administration of Ondansetron Injection for Prevention of Postoperative Nausea and Vomiting' detailing dosing recommendations, administration instructions, and timing of administration for ondansetron injection in adults and pediatric patients by weight and age groups.*

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A table titled 'Therapeutic Response in Prevention of Postoperative Nausea and Vomiting in Adult Patients' comparing ondansetron 4 mg intravenous to placebo. It details study results including emetic episodes and nausea assessments over a 24-hour postoperative period in two studies, with patient numbers, percentages, and P values showing statistical comparisons.*

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A data table titled 'Table 11. Therapeutic Response in Prevention of Postoperative Nausea and Vomiting in Pediatric Patients Aged 2 to 12 Years.' It summarizes the treatment response over 24 hours comparing Ondansetron and placebo groups across three studies, listing number of patients, percentages with zero emetic episodes, failure rates, and nausea assessments, with associated p-values indicating statistical significance.*

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A data table titled 'Therapeutic Response in Prevention of Further Postoperative Nausea and Vomiting in Adult Patients' comparing ondansetron 4 mg intravenous versus placebo in two studies. It presents numbers of patients, emetic episode counts, median time to first emetic episode, and mean nausea scores over a 24-hour postoperative period with associated p-values showing statistical significance.*

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A data table titled 'Therapeutic Response in Prevention of Further Postoperative Nausea and Vomiting in Pediatric Patients Aged 2 to 12 Years.' It compares treatment response over 24 hours between Ondansetron and placebo groups, showing number of patients, percentage with zero emetic episodes, and failure rates defined as one or more emetic episodes, rescued, or withdrawn.*

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A data table titled 'Table 2. Adverse Reactions Reported in >5% of Adult Patients Who Received Ondansetron at a Dosage of Three 0.15-mg/kg Doses.' It compares percentages of adult patients experiencing diarrhea, headache, and fever across three groups: Ondansetron Injection (0.15 mg/kg x 3, n=419), Metoclopramide (n=156), and Placebo (n=34).*

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A data table titled 'Adverse Reactions Reported in ≥2% (and with Greater Frequency than the Placebo Group) of Adult Patients Receiving Ondansetron at a Dosage of 4 mg Intravenous over 2 to 5 Minutes.' It lists adverse reactions such as headache, drowsiness/sedation, injection site reaction, fever, cold sensation, pruritus, and paresthesia with their reported frequencies in patients receiving 4 mg intravenous Ondansetron injection compared to placebo (n=547 for each group).*

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A data table titled 'Table 4. Pharmacokinetics in Normal Adult Volunteers' presenting age groups, number of subjects, peak plasma concentration (ng/mL), mean elimination half-life (hours), and plasma clearance (L/h/kg). The table compares values among three age groups: 19-40, 61-74, and 75 years or older.*

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A data table titled 'Pharmacokinetics in Pediatric Cancer Patients Aged 1 Month to 18 Years.' It compares pharmacokinetic parameters including clearance (CL), volume of distribution at steady state (Vdss), and half-life (t½) between pediatric cancer patients aged 4 to 18 years and population pharmacokinetic patients aged 1 month to 48 months. The table includes geometric mean or mean values for each group with sample sizes indicated.*

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A pharmacokinetics data table showing clearance (CL), volume of distribution at steady state (Vdss), and half-life (t½) for pediatric surgery patients aged 1 month to 12 years. The table includes geometric mean and mean values for three age groups: 3 to 12 years, 5 to 24 months, and 1 to 4 months, with sample sizes (N) for each group.*

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A data table titled 'Therapeutic Response in Prevention of Chemotherapy-induced Nausea and Vomiting in Single-day Cisplatin Therapy in Adults' comparing Ondansetron Injection (0.15 mg/kg x 3) to placebo across various response metrics including number of patients, emetic episodes, median number of episodes, median time to first episode, median nausea scores, and global satisfaction scores, with associated p-values.*

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A text panel with detailed footnotes related to a clinical study or efficacy data of Ondansetron Injection. It includes explanations of chemotherapy dosing groups, efficacy analysis, median outcomes, and visual analog scale assessments for nausea and patient satisfaction.*

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A data table titled 'Therapeutic Response in Prevention of Vomiting Induced by Cisplatin (≥100 mg/m²) Single-day Therapy in Adults' comparing Ondansetron Injection (0.15 mg/kg x 3) and Metoclopramide (2 mg/kg x 6). It details patient numbers, treatment response by emetic episodes, median number and time of emetic episodes, global satisfaction scores, and adverse reactions such as acute dystonic reactions and akathisia, including statistical P values.*

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This text panel includes footnotes from clinical data describing chemotherapy treatments received by patients, including agents like cyclophosphamide, etoposide, and fluorouracil. It explains a visual analog scale assessment ranging from 0 (not at all satisfied) to 100 (totally satisfied).*

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A data table titled 'Therapeutic Response in Prevention of Chemotherapy-induced Nausea and Vomiting in Single-day Cyclophosphamide Therapy in Adults' comparing Ondansetron Injection (0.15 mg/kg x 3) versus Placebo. The table lists number of patients, treatment response across categories of emetic episodes, median number of emetic episodes, median time to first emetic episode, median nausea scores, and global satisfaction with control of nausea and vomiting, including p-values. Footnotes explain chemotherapy agents used, analysis type, and assessment scales for nausea and satisfaction.*

FDA Label Image

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Label for ONDANSETRON injection, USP 4 mg/2 mL (2 mg/mL) single-use vial from Henry Schein, Inc. The label states the drug is for intramuscular or intravenous use only, with storage instructions to protect from light and maintain controlled room temperature (36°F to 86°F). It includes an NDC barcode, item number 2480902, and advises to see the manufacturer's insert for complete product and prescribing information.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.