Ondansetron Injection
Product Images NDC 51662-1377

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 51662-1377). 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.

FDA Label Image

Box Label (63323 0374 20 Ondansetron Inj. Box Label)

Label for Ondansetron Injection, USP 40 mg/20 mL (2 mg/mL) multiple dose vial. The label indicates the product is for intramuscular (IM) or intravenous (IV) use and is prescription only. The labeler is Fresenius Kabi USA, LLC. NDC 63323-374-20 is visible on the label.*

FDA Label Image

Vial Label (63323 0374 20 Ondansetron Inj. Label)

ONDANSETRON Injection, USP 40 mg/20 mL (2 mg/mL) multiple dose vial for intramuscular or intravenous use. The label lists active ingredient ondansetron hydrochloride with inactive ingredients and preservative details. It is a sterile product labeled for Rx only, with storage instructions from 20° to 25°C. The labeler is Fresenius Kabi USA, LLC.*

FDA Label Image

Fresenius (Fresenius)

FDA Label Image

How Supplied (How Supplied 1)

A data table presenting product information for Ondansetron injection, including product code 370302, unit of sale as NDC 63323-373-02 in a unit of 25, strength of 4 mg per 2 mL (2 mg per mL), and packaging as 2 mL single dose vial labeled NDC 63323-373-00.*

FDA Label Image

How Supplied 2 (How Supplied 2)

A data table presenting product code, unit of sale, strength, and each description for a drug product. It shows product code 370420 with unit of sale as NDC 63323-374-20 Individually Packaged, strength of 40 mg per 20 mL (2 mg per mL), and packaging as a 20 mL multiple dose vial under NDC 63323-374-20.*

FDA Label Image

Description1 (Picture 1 Description)

Chemical structure of ondansetron hydrochloride dihydrate (C18H19N3O·HCl·2H2O) with molecular weight 365.86, showing its detailed molecular formula and arrangement of atoms.*

FDA Label Image

Table 1 (Table 1)

A table detailing the recommended dose and administration instructions for Ondansetron injection for prevention of postoperative nausea and vomiting. It covers dosing for adults and pediatric patients older than 12 years, pediatric patients 1 month to 12 years and weighing more than 40 kg, and pediatric patients 1 month to 12 years weighing 40 kg or less. Instructions include intravenous and intramuscular administration specifics and timing relative to surgery.*

FDA Label Image

Table 10 (Table 10)

Table presenting therapeutic response data for ondansetron 4 mg intravenous versus placebo in preventing postoperative nausea and vomiting in adult patients. It includes study results of emetic episodes and nausea assessments over a 24-hour postoperative period in two studies, showing the number and percentage of patients with 0, 1, or more emetic episodes and no nausea.*

FDA Label Image

Table 11 (Table 11)

Table showing therapeutic response in the prevention of postoperative nausea and vomiting in pediatric patients aged 2 to 12 years treated with Ondansetron compared to placebo. The table presents patient numbers, percentage with zero emetic episodes, and failure rates across three studies and nausea assessments, including their associated P values indicating statistical significance over 24 hours.*

FDA Label Image

Table 12 (Table 12)

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 and percentages of emetic episodes, median time to first emetic episode in minutes, and mean nausea scores over a 24-hour postoperative period for evaluated patients.*

FDA Label Image

Table 13 (Table 13)

A data table showing the therapeutic response to Ondansetron versus placebo in preventing postoperative nausea and vomiting in pediatric patients aged 2 to 12 years. It presents patient numbers, percentage with zero emetic episodes, and failure rates over 24 hours, along with a p-value indicating statistical significance.*

FDA Label Image

Table 2 (Table 2)

A data table titled 'Adverse Reactions Reported in > 5% of Adult Patients Who Received Ondansetron at a Dosage of Three 0.15-mg/kg Doses.' It lists the percentage of adult patients experiencing diarrhea, headache, and fever after receiving Ondansetron Injection, Metoclopramide, or placebo. The table compares adverse reaction rates among three groups: Ondansetron Injection (n=419), Metoclopramide (n=156), and placebo (n=34).*

FDA Label Image

Table 3 (Table 3)

A data table showing adverse reactions reported in 2% or more of adult patients receiving Ondansetron Injection 4 mg intravenously, compared to a placebo group. The table lists reactions such as headache, drowsiness/sedation, injection site reaction, fever, cold sensation, pruritus, and paresthesia, with corresponding patient counts and percentages for each group.*

FDA Label Image

Table 4 (Table 4)

A pharmacokinetic data table showing peak plasma concentration, mean elimination half-life, and plasma clearance of ondansetron in normal adult volunteers across different age groups: 19 to 40 years, 61 to 74 years, and 75 years or older. The table includes sample size (n) for each group.*

FDA Label Image

Table 5 (Table 5)

A data table titled 'Pharmacokinetics in Pediatric Cancer Patients Aged 1 Month to 18 Years' comparing clearance (CL), steady-state volume of distribution (Vdss), and half-life (T1/2) between two age groups of pediatric cancer patients, with sample sizes and geometric mean or mean values presented.*

FDA Label Image

Table 6 (Table 6)

A data table titled 'Pharmacokinetics in Pediatric Surgery Patients Aged 1 Month to 12 Years' showing pharmacokinetic parameters including clearance (CL), volume of distribution at steady state (Vdss), and half-life (T1/2) in pediatric patients divided into three age groups: 3 to 12 years, 5 to 24 months, and 1 month to 4 months, with sample sizes (N) and corresponding geometric means or means for each parameter.*

FDA Label Image

Table 7 (Table 7)

A data table titled 'Therapeutic Response in Prevention of Chemotherapy-induced Nausea and Vomiting in Single-day Cisplatin Therapy in Adults' comparing outcomes between Ondansetron injection (0.15 mg/kg x 3) and placebo groups. It presents patient numbers, treatment response rates by emetic episodes, median emetic episodes, median time to first emetic episode, median nausea scores, and global satisfaction scores with nausea and vomiting control, including p-values for statistical significance.*

FDA Label Image

Table 8 (Table 8)

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 presents patient counts, treatment response rates by emetic episodes, statistical comparisons of treatments, median number and time of emetic episodes, global satisfaction scores, and incidence of acute dystonic reactions and akathisia.*

FDA Label Image

Table 9 (Table 9)

A data table titled 'Therapeutic Response in Prevention of Chemotherapy-induced Nausea and Vomiting in Single-day Cyclophosphamide Therapy in Adults.' It compares Ondansetron Injection (0.15 mg/kg x 3) and Placebo groups across several treatment response metrics including number of patients, 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, along with associated p-values.*

FDA Label Image

Serialized Label (Serialized Label)

ONDANSETRON Injection, USP 40 mg/20 mL (2 mg/mL) multiple dose vial packaging label. The label indicates use for IM or IV administration and includes the NDC 63323-374-20. The box features the Fresenius Kabi logo in blue and has a white and teal color scheme.*

* 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.