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)

The text describes a medication called Ondansetron, administered as an injection in either an intramuscular or intravenous manner. It is contained in a multiple dose vial with a volume of 20mL at a concentration of 2mg/mL. The National Drug Code (NDC) for this medication is 63323-374-20 with the associated identifier number 370420.*

FDA Label Image

Vial Label (63323 0374 20 Ondansetron Inj. Label)

ONDANSETRON INJECTION, USP is a medication for Intravenous or Intramuscular treatment. It contains 40mg in 20mL of medication. It is packaged in a multiple-dose vial and the NDC for this vial is 63323-374-20 370420.*

FDA Label Image

Fresenius (Fresenius)

FDA Label Image

How Supplied (How Supplied 1)

This text is a product code for a medication with strength of 4mg per 2mL (2mg per mL). It is available as a single-dose vial containing 2ml, and is sold in units of 25. The NDC number for this product is 63323-373-02.*

FDA Label Image

How Supplied 2 (How Supplied 2)

This is a product with a product code of 370420 which is available in a unit of sale with strength of 40 mg per 20 mL (2 mg per ml). The unit is individually packaged and is in a 20 mL multiple dose vial.*

FDA Label Image

Description1 (Picture 1 Description)

FDA Label Image

Table 1 (Table 1)

The text provides the recommended dose and administration instructions for Ondansetron Injection to prevent postoperative nausea and vomiting in both adult and pediatric patients. The recommended dose for adults and pediatric patients older than 12 years of age is 4mg, which can be administered intravenously or intramuscularly. For pediatric patients between 1 month and 12 years of age and weighing more than 40 kg, the recommended dose is also 4mg, given intravenously over at least 30 seconds. Pediatric patients weighing 40 kg or less should receive 0.1 mg/kg of Ondansetron Injection. The timing of administration is immediately before anesthesia induction or postoperatively within 2 hours after surgery if the patient experiences nausea or vomiting despite prophylactic antiemetics.*

FDA Label Image

Table 10 (Table 10)

The table presents the results of two studies on the prevention of postoperative nausea and vomiting in adults using Ondansetron 4mg and Placebo. The results are presented as treatment responses over a 24-hour postoperative period, including the number of emetic episodes and nausea assessments for each study. The response rates and P values are also provided, indicating the effectiveness of Ondansetron 4mg in reducing nausea and vomiting after surgery.*

FDA Label Image

Table 11 (Table 11)

This is a table demonstrating therapeutic response in preventing nausea and vomiting post-surgery in pediatric patients between the ages of 2 and 12 years. The table shows the percentage of patients responding to treatment using Ondansetron compared to Placebo over a period of 24 hours. The table shows results from three studies, each containing a different number of patients. The table also includes the number of patients who experienced nausea, and the number of patients who had no nausea.*

FDA Label Image

Table 12 (Table 12)

The table shows the therapeutic response of Ondansetron 4 mg Intravenous compared to Placebo in preventing postoperative nausea and vomiting in adult patients. The response is based on emetic episodes and nausea assessments over 24 hours after the study drug was administered. The data is presented separately for Study 1 and Study 2, with treatment response, P values, and median time to first emetic episode given for each study. Mean nausea scores are also included for both studies.*

FDA Label Image

Table 13 (Table 13)

The text describes a table (Table 13) showing therapeutic response of ondansetron and placebo in pediatric patients aged 2 to 12 years in the prevention of further postoperative nausea and vomiting over 24 hours. It includes information on the number of patients, percentage of emetic episodes, failure rates and p-value.*

FDA Label Image

Table 2 (Table 2)

Table 2. Adverse Reactions Reported in > 5% of Adult Patients Who Received Ondansetron at a Dosage of Three 0.15-mg/kg Doses: This table provides information about adverse reactions reported in adult patients who received Ondansetron at a dosage of three 0.15-mg/kg doses. The table lists adverse reactions like diarrhea, headache, and fever along with the number of adult patients who experienced those reactions after receiving the medication. The number of patients who received Metoclopramide and Placebo is also given in the table for comparison purposes.*

FDA Label Image

Table 3 (Table 3)

Table 3. 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: This table provides a list of adverse reactions experienced by adult patients receiving Ondansetron Injection 4 mg Intravenous over 2 to 5 minutes. The adverse reactions reported in more than 2% of patients and with greater frequency than the placebo group include headache, drowsiness/sedation, injection site reaction, fever, cold sensation, pruritus, and paresthesia.*

FDA Label Image

Table 4 (Table 4)

This is a table titled "Table 4" that displays Pharmacokinetics in Normal Adult Volunteers. The table has three columns: Age-group (in years), n (number of individuals in the age group), and pharmacokinetic parameters. The pharmacokinetic parameters include peak plasma concentration, mean plasma clearance (LUh/kg), and half-life (in hours). The age groups listed are 19-40, 61-74, and 27-5 years old. Not available.*

FDA Label Image

Table 5 (Table 5)

This is a table presenting pharmacokinetic data of cancer patients aged 1 month to 18 years. The table provides the number of subjects in each age group, the geometric mean and mean values for clearance (CL), volume of distribution (Vd), and terminal half-life (T1/2) in hours. The table includes data of 21 patients aged 4 to 18 years and 115 population PK patients aged 1 month to 48 months.*

FDA Label Image

Table 6 (Table 6)

This text provides a table summarizing the pharmacokinetics of pediatric surgery patients aged 1 month to 12 years. The table includes three age groups (3 to 12 years, 5 to 24 months, and 1 month to 4 months) with the respective number of subjects (N) for each group. The table shows the geometric mean and mean values for clearance (CL), volume distribution (Vdes), and duration of infusion (Ta) for each age group.*

FDA Label Image

Table 7 (Table 7)

The text represents a table showing the therapeutic response in the prevention of chemotherapy-induced nausea and vomiting using Single-day Cisplatin Therapy in adults. The table compares the effects of Ondansetron injection and Placebo. The number of patients and treatment responses are reported. The frequency of emetic episodes, median time to first emetic episode, and median nausea scores are also provided. The table shows the global satisfaction with control of nausea and vomiting for both treatments.*

FDA Label Image

Table 8 (Table 8)

This is a table that shows the therapeutic response to prevent vomiting induced by cisplatin in adults. The table compares the effectiveness of the drugs Ondansetron and Metoclopramide Injection. It reports various aspects such as the number of patients, treatment responses, comparison of treatments with respect to emetic episodes, median number, and time to first emetic episode, global satisfaction with the control of nausea and vomiting, and acute dystonic reactions.*

FDA Label Image

Table 9 (Table 9)

This table presents the therapeutic response to prevent chemotherapy-induced nausea and vomiting using single-day cyclophosphamide therapy in adults. The table shows two treatment options, ondansetron injection, and placebo. The number of patients under each treatment is ten, and their response to treatment in terms of the number of emetic episodes and nausea scores is measured. The table also shows global satisfaction with the control of nausea and vomiting.*

FDA Label Image

Serialized Label (Serialized Label)

This text provides information about a medicine with the National Drug Code (NDC) 63323-374-20, named Ondansetron, which is an injection recommended for medical purposes in the United States Pharmacopeia (USP).*

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