Ondansetron Tablet, Film Coated
Product Images NDC 51662-1678

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 51662-1678). 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

Table (51662 1678 1 Table 1 And 2)

Two tables presenting recommended dosage regimens for prevention of nausea and vomiting. The first table covers adult dosages including indications for highly emetogenic cancer chemotherapy, moderately emetogenic chemotherapy, radiotherapy, and postoperative use. The second table presents pediatric dosage recommendations for moderately emetogenic cancer chemotherapy across specific age groups.*

FDA Label Image

Label (51662 1678 1 Rfilabel)

Packaging label for ONDANSETRON 4 mg film-coated tablets distributed by HF Acquisition Co., LLC, Mukilteo, WA 98275. The label includes product identification numbers with a barcode and the text 'RX ONLY' indicating prescription status. It instructs the user to see the manufacturer's insert for more information.*

FDA Label Image

Structure (51662 1678 1 Structure)

Chemical structure of ondansetron hydrochloride dihydrate, showing the molecular arrangement including indole and imidazole rings with associated methyl groups and hydrate components.*

FDA Label Image

Table (51662 1678 1 Table 3)

A table titled 'Most Common Adverse Reactions in Adults for the Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy.' It compares adverse reactions including headache, malaise/fatigue, constipation, and diarrhea in patients receiving Ondansetron 8 mg twice daily versus placebo, showing the number and percentage of affected individuals in each group.*

FDA Label Image

Table (51662 1678 1 Table 4)

A data table titled 'Most Common Adverse Reactions in Adults' comparing the frequency of various adverse reactions in patients receiving a single dose of Ondansetron 16 mg versus placebo groups. Reactions listed include headache, hypoxia, pyrexia, dizziness, gynecological disorder, anxiety/agitation, urinary retention, and pruritus, with respective percentages and patient counts for each treatment group.*

FDA Label Image

Table (51662 1678 1 Table 5 And 6)

Two pharmacokinetic data tables showing measurements in male and female healthy subjects after a single dose of ondansetron tablets. The first table presents data for an 8 mg tablet, including mean weight, peak plasma concentration, time of peak plasma concentration, mean elimination half-life, systemic plasma clearance, and absolute bioavailability by age and sex. The second table shows similar data for a 24 mg tablet, including mean weight, peak plasma concentration, time to peak concentration, and mean elimination half-life by age and sex.*

FDA Label Image

Table (51662 1678 1 Table 7)

A data table titled 'Emetic Episodes-Treatment Response in Patients Receiving Moderately Emetogenic Chemotherapy (Cyclophosphamide-based Regimen Containing Doxorubicin)'. It compares treatment responses between patients receiving Ondansetron (n=33) and Placebo (n=34), including the number and timing of emetic episodes and associated p-values for statistical significance.*

FDA Label Image

Label (51662 1678 1 Table 8)

A data table titled 'Table 8: Emetic Episodes-Treatment Response After Ondansetron Tablets Administered Twice a Day and Three Times a Day.' It compares treatment responses, median number of emetic episodes, median time to first emetic episode, and median nausea scores for patients taking 8 mg ondansetron tablets twice daily versus three times daily.*

* 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.