Ondansetron Injection
Product Images NDC 51662-1366

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 51662-1366). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hf Acquisition Co Llc, Dba Healthfirst, 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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Adverse 1 (Adverse Reactions 1)

Data table showing the number of adult patients experiencing adverse reactions during treatment with Ondansetron Injection 0.15 mg/kg x 3 (n=419), Metoclopramide (n=156), or Placebo (n=34). Adverse reactions listed include diarrhea, headache, and fever, with corresponding percentages for each treatment group.*

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Adverse 2 (Adverse Reactions 2)

This data table compares the adverse reactions reported in a clinical study of Ondansetron Injection 4 mg intravenous versus placebo, each with 547 patients. It lists various adverse reactions such as headache, drowsiness/sedation, injection site reaction, fever, cold sensation, pruritus, and paresthesia, with their corresponding incidence rates in number and percentage for both Ondansetron and placebo groups.*

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Clinic P 1 (Clinic P 1)

A data table presenting pharmacokinetic parameters of ondansetron injection by age group. It includes age groups (19 to 40, 61 to 74, and 75 or older), sample size (n), peak plasma concentration (ng/mL), mean elimination half-life (hours), and plasma clearance (L/h/kg). Values show changes in these measures across age groups.*

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Clinic P 2 (Clinic P 2)

A data table comparing pharmacokinetic parameters in pediatric cancer patients aged 4 to 18 years and a population of patients aged 1 to 48 months. Parameters include number of subjects (N), clearance (CL), volume of distribution at steady state (Vdss), and half-life (T1/2) with geometric mean and mean values listed.*

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Clinic P 3 (Clinic P 3)

A data table presenting pharmacokinetic parameters of Ondansetron injection in pediatric surgery patients across three age groups: 3 to 12 years, 5 to 24 months, and 1 to 4 months. The table lists sample sizes (N), clearance (CL in L/h/kg), steady-state volume of distribution (Vdss in L/kg), and half-life (T1/2 in hours) with geometric means and means provided.*

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Clinical S 1 (Clinical S 1)

A data table comparing clinical outcomes between Ondansetron Injection (0.15 mg/kg x 3) and placebo groups. It includes patient numbers, treatment response categories for emetic episodes, median number and time to first emetic episodes, median nausea scores, and global satisfaction scores, with corresponding p-values indicating statistical significance.*

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Clinical S 2 (Clinical S 2)

A data table comparing treatment efficacy and side effects between Ondansetron Injection (0.15 mg/kg x 3) and Metoclopramide (2 mg/kg x 6) in a patient population. It presents metrics such as number of emetic episodes, time to first emetic episode, global satisfaction scores, and incidence of acute dystonic reactions and akathisia, alongside corresponding p-values for statistical significance.*

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Clinical S 3 (Clinical S 3)

A data table comparing treatment responses between Ondansetron Injection (0.15 mg/kg x 3) and Placebo groups, each with 10 patients. It reports numbers and percentages of emetic episodes, median number of emetic episodes, median time to first emetic episode, median nausea scores, and global satisfaction scores, alongside P values for statistical significance.*

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Clinical S 4 (Clinical S 4)

A data table comparing Ondansetron 4 mg Intravenous with placebo over two studies. It presents emetic episode counts (0, 1, more than 1 or rescued) and nausea assessments (number of patients with no nausea) during a 24-hour postoperative period, including patient numbers and percentages, along with associated p-values indicating statistical significance.*

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Clinical S 5 (Clinical S 5)

A data table presenting treatment response over 24 hours comparing Ondansetron and placebo across three studies. It includes patient numbers, percentages of zero emetic episodes, failure rates, and nausea assessments with associated P values indicating statistical significance.*

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Clinical S 5 (Clinical S 6)

A data table summarizing clinical study results comparing Ondansetron 4 mg Intravenous with placebo. It presents emetic episode counts, median time to first emetic episode (minutes), and mean nausea scores over 24 hours post-study drug for two separate studies. The table includes number of patients, treatment responses, and P values indicating statistical significance.*

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Clinical S 7 (Clinical S 7)

A data table presenting treatment response over 24 hours comparing Ondansetron and placebo groups. It includes patient counts and percentages for emetic episodes and failures, along with a P value indicating statistical significance.*

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Highlights (Highlights)

A dosage table for Ondansetron Injection detailing dosage and intravenous infusion rates by population groups: Adults over 12 years receive 4 mg once over 2 to 5 minutes; Pediatrics over 1 month to 12 years and weighing more than 40 kg receive the same; Pediatrics 1 month to 12 years weighing 40 kg receive 0.1 mg/kg once over 2 to 5 minutes.*

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How Supplied 1 (How Supplied 1)

A data table listing a product with NDC number 63323-373-02, strength 4 mg per 2 mL (2 mg per mL), and vial size of 2 mL fill in a 2 mL vial, packaged in trays of 25.*

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How Supplied 2 (How Supplied 2)

A table listing product information including product number, NDC number, strength, and vial size. It shows a product with NDC 63323-374-20, strength 40 mg per 20 mL (2 mg per mL), and vial size as 20 mL fill in a 20 mL vial packaged individually.*

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Logo (Logo)

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Serialized Labeling (Serialized Labeling)

Ondansetron Injection, USP 2 mg/mL is shown in a 2 mL single-dose vial with a brown glass body and a light blue cap. The label indicates the drug is for intramuscular or intravenous use and lists the manufacturer as HF Acquisition Co., LLC. The vial includes a barcode and additional product identification numbers.*

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Structure (Structure)

Chemical structure of ondansetron hydrochloride dihydrate (C18H19N3O·HCl·2H2O) with molecular weight 365.86, depicting the arrangement of atoms including a fused bicyclic ring and imidazole group.*

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Vial Label (Vial Label)

ONDANSETRON injection USP label for a 2 mL single dose vial with 4 mg per 2 mL (2 mg/mL) strength. The label indicates it is for intramuscular or intravenous use with usual dosage details referenced to the insert. Manufactured by Fresenius Kabi USA, LLC, the label includes an NDC 63323-373-02 and barcode.*

* 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.