Ondansetron Tablet, Orally Disintegrating
Product Images NDC 51662-1246

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 51662-1246). 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

Blister Package (1246 4 Blister Pack Resized)

Packaging labels for Ondansetron Orally Disintegrating Tablet USP 4 mg from HF Acquisition Co LLC, DBA HealthFirst, NDC 51662-1246, shown in a punched strip of four individual labels. Each label includes prescription status, dosage form and strength, warnings about phenylketonurics, distributor information, lot number, expiration date, and barcodes.*

FDA Label Image

51662-1246-4 Serialized Bag (1246 4 Serialized Labeling Resized)

ONDANSETRON 4 mg orally disintegrating tablets in a small resealable plastic bag. The visible blister pack shows individual tablets with printed text including the drug name, strength, form, and NDC number. The bag features a white label with barcodes, lot number, expiration date, and manufacturer distributor information (HF Acquisition Co LLC, Mukilteo, WA). Marked RX ONLY.*

FDA Label Image

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ONDANSETRON 4 mg orally disintegrating tablet shown on a gray background with a millimeter scale. The white round tablets are embossed with 'E' on one side inside a circle and '5' on the opposite side. No packaging or label information is visible in the image.*

FDA Label Image

Adverse 1 (Adverse 1)

Table presenting adverse reactions reported for Ondansetron Orally Disintegrating Tablets 8 mg twice daily compared to placebo in clinical trials. Common reactions include headache, malaise/fatigue, constipation, and diarrhea, with corresponding counts and percentages for each group.*

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Adverse 2 (Adverse 2)

A data table presenting the incidence of various adverse reactions observed in patients taking Ondansetron Orally Disintegrating Tablets 16 mg as a single dose (n=550) compared to a placebo group (n=531). Adverse reactions include headache, hypoxia, pyrexia, dizziness, gynecological disorder, anxiety/agitation, urinary retention, and pruritus, with percentages and counts reported for each group.*

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Clinical 1 (Clinical Pharma 1)

A data table presenting pharmacokinetic parameters of Ondansetron across different age and sex groups. It shows mean weight, sample size (N), peak plasma concentration (ng/mL), time of peak plasma concentration (hours), mean elimination half-life (hours), systemic plasma clearance (L/h/kg), and absolute bioavailability for males and females aged 18 to over 75 years.*

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Clinical Pharma 2 (Clinical Pharma 2)

A table presenting pharmacokinetic data for an age group 18 to 43 years divided by sex (male and female). It lists mean weight, sample size (N), peak plasma concentration (ng/mL), time of peak plasma concentration (hours), and mean elimination half-life (hours). Females showed higher peak plasma concentration and longer elimination half-life than males in this dataset.*

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Clinical Studies 1 (Clinical Studies 1)

A data table comparing treatment response outcomes between Ondansetron Orally Disintegrating Tablets (33 subjects) and a placebo group (34 subjects). It shows the number and percentage of subjects with 0, 1 to 2, and more than 2 emetic episodes, median number of emetic episodes, and median time to first emetic episode in hours, along with P values indicating statistical significance.*

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Clinical Studies 2 (Clinical Studies 2)

Data table showing treatment response for Ondansetron tablets with dosing of 8 mg twice daily and 8 mg three times daily. It presents the number and percentage of patients with 0, 1 to 2, or more than 2 emetic episodes, along with median number of emetic episodes, median time to first emetic episode, and median nausea scores on a 0 to 100 scale.*

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Dosage 1 (Dosage 1)

A data table showing dosage regimens for Ondansetron related to different indications including highly emetogenic cancer chemotherapy, moderately emetogenic cancer chemotherapy, radiotherapy (with distinct regimens for total body irradiation, single high-dose fraction to the abdomen, and daily fractionated to the abdomen), and postoperative use. The table details specific dose amounts and timing before and after treatments.*

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Dosage 2 (Dosage 2)

A data table presenting dosage regimens of Ondansetron for moderately emetogenic cancer chemotherapy. It specifies dosing instructions for two age groups: 12 to 17 years and 4 to 11 years, including timing and amounts of doses before and after chemotherapy completion.*

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Structure (Structure)

Chemical structure of Ondansetron, showing its molecular framework with characteristic rings and functional groups.*

* 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.