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)

This is a table showing the adverse reactions of three drugs namely Ondansetron Injection, Metoclopramide, and Placebo. The number of adult patients with reactions such as diarrhea, headache, and fever are also included.*

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Adverse 2 (Adverse Reactions 2)

This is a report on adverse reactions observed in patients who received Ondansetron Injection and Placebo intravenously. A total of 547 patients received both Ondansetron Injection and Placebo, respectively. Adverse reactions such as headache, drowsiness, sedation, injection site reaction, fever, cold sensation, pruritus, and paresthesia were observed in varying percentages among the patients. The report does not provide more information, and non-English characters are not present.*

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Clinic P 1 (Clinic P 1)

This seems to be a numerical data table related to the concentration and elimination of some plasma content for certain age groups. The age group is mentioned in years and the table shows the values of peak plasma concentration, mean plasma clearance, and elimination half-life of the plasma content. The data appears to be separated into three different age groups - 19 years, 40 years, and 61-74 years. Unfortunately, there isn't any contextual information provided to determine what the plasma content refers to or the purpose of the study.*

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Clinic P 2 (Clinic P 2)

The text provides information about the subjects and age groups in two studies. The first study includes pediatric cancer patients with a sample size (N) of 21 and an age range of 18 years. The second study includes population pharmacokinetics patients with an age range of 1 month to 48 months and a sample size of 115. The text also shows the geometric mean and mean for volume of distribution and clearance in these groups.*

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Clinic P 3 (Clinic P 3)

This is a table that displays the geometric mean, mean and standard deviation for the clearance (N a), volume of distribution at steady state (Vdgs) and elimination half-life (Tip) of pediatric surgery patients divided into different age groups. The age groups are 3 to 12 years, 5 to 24 months, and 1 month to 4 months.*

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Clinical S 1 (Clinical S 1)

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Clinical S 2 (Clinical S 2)

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Clinical S 3 (Clinical S 3)

This is a report of a clinical trial evaluating the effectiveness of ondansetron injection (Palue®) in reducing emetic episodes and nausea in patients. The placebo group (10 patients) had a higher rate of emetic episodes, with some needing rescue treatments, compared to the group treated with ondansetron (also 10 patients). The median number of emetic episodes and nausea scores were lower in the treatment group, and patients reported higher satisfaction with the control of their symptoms.*

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Clinical S 4 (Clinical S 4)

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Clinical S 5 (Clinical S 5)

This appears to be a medical study evaluating the effectiveness of ondansetron versus a placebo in reducing emetic episodes (vomiting) and nausea in patients over 24 hours. The study is broken down into three separate trials with varying numbers of patients and different rates of success/failure between the two treatment groups. The results suggest that ondansetron may be more effective than the placebo in reducing emetic episodes and nausea.*

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Clinical S 5 (Clinical S 6)

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Clinical S 7 (Clinical S 7)

The text describes the results of a treatment response study comparing the drugs Ondansetron and Placebo over a 24-hour period. The study collected data on the number of patients with zero episodes of vomiting and measures of treatment failure. The results showed that Ondansetron had a statistically significant lower rate of treatment failure compared to Placebo.*

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Highlights (Highlights)

This text provides dosage information for ondansetron infusion in different age groups and weight ranges. For adults over 12 years old, a 4mg dose is given over 2 to 5 minutes. For pediatric patients aged 1 month to 12 years and weighing over 40 kg, the same 4mg dose is given over the same time period. For pediatric patients aged 1 month to 12 years and weighing less than or equal to 40 kg, a dose of 0.1mg/kg is given over 2 to 5 minutes. This information may be useful for healthcare professionals prescribing or administering ondansetron infusion.*

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How Supplied 1 (How Supplied 1)

This is a description of a medication identified by the Product NDC number 370302. It has a strength of 4 mg per 2 mL and comes in a 2 mL vial. The medication is packaged in trays that contain 25 vials with each vial containing 2 mg per 25 mL.*

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How Supplied 2 (How Supplied 2)

This is a product with National Drug Code (NDC) number 63323-374-20 and product number 370420. It has a strength of 40 mg per 20 mL (2 mg per mL) fill and is packaged in a 20 mL vial, sold individually.*

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Logo (Logo)

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Serialized Labeling (Serialized Labeling)

This appears to be a medication label containing information about a drug called Ondansetron. It is available in a single dose vial and contains 4mg/2mL of the medication. The label indicates that there is a manufacturer's package insert available to view for more information about the drug, and it is distributed by a company called HF Acquisition Co., LLC. The usual dosage is also mentioned, but further details are not provided.*

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Structure (Structure)

This text appears to be a chemical formula and information related to it. The formula is HCl+2H2O, which represents hydrochloric acid dissolved in two water molecules. The text also mentions CuH|.N,0 HCI ‘2"20 M.W. 365.86 which may be referring to a copper compound, but further context is needed to provide a more accurate description.*

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Vial Label (Vial Label)

This is a description of a drug product with the NDC code 63323-373-02. The drug is Ondansetron injection, USP, with a strength of 4 mg/2 mL (2mg/mL). The drug is for "ForlMorlVUse Rxonly" and the recommended dosage is to be found in "sert". The drug is packaged in a single-dose vial with a volume of 2 mL. The manufacturer is Fresenius Kabl USA, LLC. There is also a LOT/EXP number (402170C) and some additional numbers (63323-373-02 3) present, which may be related to the packaging or tracking of the product.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.