Ondansetron Tablet, Orally Disintegrating
Product Images NDC 51662-1514

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 51662-1514). 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

Serialized Bag Labeling (1514 1 Serialized Package Label)

Ondansetron 4 mg orally disintegrating tablets are shown in a small transparent resealable plastic bag. The bag contains a blister card with two round tablets visible. The label on the blister includes drug name, strength, distributor information HF Acquisition Co LLC, batch number, and an expiration date of AUG 2023. A white sticker on the bag displays barcodes and additional distributor details.*

FDA Label Image

Blister Pack Labeling (51662 1514 Blister Pack Labeling)

Ondansetron Orally Disintegrating Tablet, USP 4 mg label showing the product is prescription only with a barcode, distributed by Rising Health, LLC in Saddle Brook, NJ. The label includes a phenylketonurics warning about phenylalanine, batch number ODO419024A, and expiration date AUG 2023. Instructions to bend and tear the package are also visible.*

FDA Label Image

57237 077 10 Ondansetron 2 Pack Hf Label Image

ONDANSETRON 4 mg orally disintegrating tablet in a single blister pack sealed inside a small clear plastic bag. The label identifies the product as an orally disintegrating tablet containing 4 mg of Ondansetron. Distributed by HF Acquisition Co LLC, with additional text indicating manufacturer details and product codes. The blister contains one round white tablet.*

FDA Label Image

Adverse 1 (Adverse 1)

A data table titled 'Most Common Adverse Reactions in Adults for the Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Chemotherapy Primarily Cyclophosphamide-based Regimens.' It compares adverse reactions reported in patients taking Ondansetron Orally Disintegrating Tablets 8 mg twice daily (n=242) versus a placebo group (n=262). Adverse reactions listed include headache, malaise/fatigue, constipation, and diarrhea with respective incidence percentages in both groups.*

FDA Label Image

Adverse 2 (Adverse 2)

Table listing the most common adverse reactions in adults for prevention of postoperative nausea and vomiting, comparing Ondansetron Orally Disintegrating Tablets 16 mg single dose to placebo. It shows the frequency and percentage of reactions like headache, hypoxia, pyrexia, dizziness, gynecological disorder, anxiety/agitation, urinary retention, and pruritus in each group.*

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Clinical P (Clinical P)

Two tables presenting pharmacokinetic data for Ondansetron tablets after a single dose in healthy male and female subjects. Table 5 shows data for 8 mg tablets, including age group, mean weight, sample size, peak plasma concentration, time of peak plasma concentration, mean elimination half-life, systemic plasma clearance, and absolute bioavailability by sex and age groups. Table 6 shows data for 24 mg tablets, presenting similar parameters except systemic plasma clearance and bioavailability are not included.*

FDA Label Image

Clinical S 1 (Clinical S 1)

A data table titled 'Emetic Episodes-Treatment Response in Patients Receiving Moderately Emetogenic Chemotherapy (Cyclophosphamide-based Regimen Containing Doxorubicin)'. It compares treatment response between Ondansetron Orally Disintegrating Tablets (n=33) and Placebo (n=34), showing emetic episode counts, median number of episodes, and median time to first episode with corresponding P values for statistical significance.*

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Clinical S 2 (Clinical S 2)

A data table titled 'Emetic Episodes-Treatment Response after Ondansetron Tablets Administered Twice a Day and Three Times a Day,' comparing treatment response metrics for Ondansetron 8 mg tablets taken twice daily (n=165) versus three times daily (n=171). It includes categories like number of emetic episodes, median emetic episodes, median time to first emetic episode, and median nausea scores measured on a 0 to 100 scale.*

FDA Label Image

Dosage (Dosage And Administration)

Two tables presenting adult and pediatric recommended dosage regimens of ondansetron for the prevention of nausea and vomiting. Dosage varies by indication such as highly emetogenic cancer chemotherapy, moderately emetogenic cancer chemotherapy, radiotherapy, and postoperative use, with specific dose timing and amounts detailed by patient age groups.*

FDA Label Image

Structure (Structure)

Chemical structure of ondansetron, showing its molecular framework including fused rings and functional groups, representing the active ingredient in ondansetron tablets.*

* 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.