Ondansetron Injection, Solution
Product Images NDC 51662-1469

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 51662-1469). 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 2 (Adverse 2)

This text provides adverse reaction data for ondansetron injection given intravenously in 4mg dosage. Common side effects include headache, drowsiness/sedation, injection site reaction, fever, cold sensation, pruritus, and paresthesia.*

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Adverse 1 (Adverse 1)

The text describes the percentage of adult patients who experienced adverse reactions after being administered Ondansetron Injection or Metoclopramide. The adverse reactions included diarrhea, headache, and fever. The table shows the percentages of patients who experienced each symptom for both medications.*

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Clinical P 1 (Clinical P 1)

This table shows the peak and mean elimination plasma clearance, plasma half-life, and concentration for different age groups. The age groups range from 19-40 years old to 61-74 years old. The data appears to relate to pharmacokinetics or drug metabolism.*

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Clinical P 2 (Clinical P 2)

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Clinical P 3 (Clinical P 3)

This appears to be a list of patients who underwent pediatric surgery and their age ranges, categorized by different patient codes. The age ranges are given in months or years.*

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Clinical S 1 (Clinical S 1)

This is a summary of a study related to the treatment response of Ondansetron injection at a dosage of 0.15mg/kg x 3 in 14 patients suffering from emetic episodes. The results show that the medication effectively reduced the number of emetic episodes and improved global satisfaction with control of nausea and vomiting. Furthermore, the medication resulted in a lower median nausea score, lower percentage of emetic episodes, and a shorter median time to first emetic episode in comparison to the control group.*

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Clinical S 3 (Clinical S 3)

This text appears to be a table showing the number of patients and their treatment responses to the medication Ondansetron Injection. The table includes measures such as the number of emetic episodes, median nausea scores, and global satisfaction with control of nausea and vomiting. It is unclear what the unit of measurement is for some of the values, such as the median time to the first emetic episode.*

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Clinical S 4 (Clinical S 4)

The text presents findings from two studies on treatment responses for postoperative emetic episodes and nausea assessments. Study 1 included 136 and 139 patients, while study 2 involved 136 and 143 patients. The percentage of patients experiencing emetic episodes decreased when the treatment was administered, and fewer patients experienced more than one episode or needed to be rescued. The number of patients who reported having no nausea over a 24-hour postoperative period increased in both studies with treatment, although some patients still experienced nausea after treatment.*

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Clinical S 5 (Clinical S 5)

This text provides data on the treatment response of ondansetron versus placebo in three different studies. The studies measured the number of emetic episodes and failures in patients over 24 hours. The results show that ondansetron was more effective in reducing emetic episodes and failures compared to the placebo. The text also presents data on nausea assessments for a subset of patients in one of the studies.*

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Clinical S 6 (Clinical S 6)

This document appears to be a study of the effectiveness of the drug Ondansetron 4 when administered intravenously for the prevention of emetic episodes (vomiting) and nausea in postoperative patients. The study was conducted over two primarily separate trials, detailing emetic episode frequencies, treatment response, median time to first emetic episode, as well as nausea assessments including the number of patients and mean score over a 24-hour period.*

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Clinical S 7 (Clinical S 7)

This is a table presenting the treatment response of patients after 24 hours of treatment with ondansetron and a placebo. The response is measured in terms of the number of emetic episodes. The table shows that out of 180 patients, 96 (53%) in the ondansetron group had no emetic episodes compared to 29 (17%) in the placebo group. The results are statistically significant with a p-value <0.001. The table also shows that 84 (47%) patients in the ondansetron group had treatment failure compared to 142 (83%) in the placebo group.*

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Dosage (Dosage)

This text provides administration instructions for the recommended single dose of a medication for patients of different age groups and weights. The medication can be administered intravenously or intramuscularly, depending on the patient's age group and weight. The recommended infusion time is at least 30 seconds or preferably longer, and the medication can be given before anesthesia or postoperatively if the patient experiences nausea or vomiting after surgery.*

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How Supplied (How Supplied)

This text provides information about the concentration of two different pharmaceutical products, including the NDC number, the concentration level (in mg/mL), and the unit of sale for each product. The first product is sold as a carton of 25 single-dose vials, each containing 2 mL of a solution with a concentration level of 4mg/2mL. The second product is sold as a single 20 mL multiple-dose vial with a concentration level of 40 mg/20 mL.*

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Logo (Logo)

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Serialized Labeling (Serialized Labeling)

This is a description of a medication called "Ondansetron Injection, USP" stored in a Single-use Vial. The National Drug Code (NDC) is 62004017713, and it is manufactured by Hospira Inc. The number (01) 00351662146910 is also provided. It is advised to read the manufacturer's package insert before use, and the medication should be protected from light during storage. The distributor is HF Acquisition Co., LLC located in Mukilteo, WA 98275.*

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Structure (Structure)

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Vial Label Option 1 (Vial Label Option 1)

This is a description of a 2mL Single-dose vial of Ondansetron Injection, USP. The product has a concentration of 2mg/ml or 4mg/2mL. The NDC number is OMMSSVWIS g i, and the product should be protected from light. It is distributed by Hospira, Inc, in Lake Forest, IL.*

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Vial Labe Option 3 (Vial Label Option 3)

This is a 2mL single-use vial of Ondansetron injection with a strength of 4mg/2mL (2mg/mL). It has an NDC code of 0409-4755-18 and is manufactured by Hospira, Inc. Batch details are to be found on the area specified.*

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Vial Label Option 2 (Viallabel Option 2)

This is a medication description for Ondansetron, which comes in a 2 mL single-dose vial. Each vial has an NDC code of 0409-4755-18 and contains an injection of Ondansetron USP at a concentration of 2 mg/mL. The medication should be protected from light, and it is distributed by Hospira, Inc. located in Lake Forest, IL 60045, USA.*

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Clinical S 2 (Clinical S 2)

The text describes the effectiveness of two different medications, ondansetron and metoclopramide, in preventing vomiting and nausea in a group of 136 and 138 patients, respectively. It includes the dosage and treatment response, divided into categories based on the number of emetic episodes, as well as the median number of emetic episodes and the median time to the first episode. The text reports that ondansetron was more effective than metoclopramide in controlling emetic episodes and patient satisfaction. Additionally, it notes that metoclopramide had a higher frequency of acute dystonic reactions and akathisia.*

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