Ondansetron Tablet, Film Coated
Product Images NDC 51662-1539

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 51662-1539). 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

Tablet Labeling (51662 1539 1 (0904 6551 61) Ondansetron Tablets Usp 4mg Packaging Image (1) Tablet Labeling)

The label is for ONDANSETRON TABLETS USP 4 mg, oral film-coated tablets, manufactured by Major Pharmaceuticals. It indicates unit dose packaging containing 100 tablets, prescription only status, and includes storage instructions, dosage reference, and manufacturer/distributor information. The label features the Major Pharmaceuticals logo and NDC 0904-6551-61.*

FDA Label Image

Bag Back Labeling (51662 1539 1 Ondansetron Hf Label Back)

ONDANSETRON 4 mg oral film-coated tablets in a small clear resealable plastic bag. The bag contains folded paper labels showing the product name Ondansetron, 4 mg USP, one tablet, with the labeler Major Pharm., Livonia, MI. The labels include NDC 0904-6551-61 and an expiration date of 09/2022.*

FDA Label Image

Serialized Front Bag Labeling (51662 1539 1 Ondansetron Hf Label Front Serialized)

Partial view of a sealed plastic bag containing a blister pack with round tablets. The label on the bag includes a barcode, numeric codes, and text indicating distribution by HF Acquisition Co., LLC, Mukilteo, WA, with instructions to see the manufacturer's package insert. The product is Ondansetron, oral film-coated tablets, 4 mg strength, by HF Acquisition Co LLC DBA HealthFirst.*

FDA Label Image

Adverse 1 (Adverse 1)

A data table comparing adverse reactions between Ondansetron 8 mg taken twice daily (n=242) and placebo (n=262). It shows the number and percentage of patients experiencing headache, malaise/fatigue, constipation, and diarrhea for both groups.*

FDA Label Image

Adverse 2 (Adverse 2)

A table presenting adverse reaction rates comparing Ondansetron 16 mg single dose (n=550) with placebo (n=531). It lists adverse reactions such as headache, hypoxia, pyrexia, dizziness, gynecological disorders, anxiety/agitation, urinary retention, and pruritus, showing corresponding number and percentage of cases in each group.*

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Cp (Clinical Pharmacology)

Two tables presenting pharmacokinetics data in male and female healthy subjects after a single dose of Ondansetron tablets at 8 mg and 24 mg strengths. The tables summarize age, sex, mean weight, sample size, peak plasma concentration, time of peak plasma concentration, mean elimination half-life, systemic plasma clearance, and absolute bioavailability.*

FDA Label Image

Cs1 (Clinical Studies 1)

A data table comparing Ondansetron (33 subjects) and Placebo (34 subjects) in terms of the number and timing of emetic episodes. It includes percentages of subjects with 0, 1, or more than 2 emetic episodes or withdrawn, median number of emetic episodes, and median time to first emetic episode in hours, with statistical P values. Some values are marked as undefined.*

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Cs2 (Clinical Studies 2)

A data table comparing outcomes for Ondansetron tablets at doses of 8 mg twice daily versus 8 mg three times daily. It shows treatment response rates for emetic episodes 1-2, median number of emetic episodes, median time to first emetic episode, and median nausea scores.*

FDA Label Image

Dosage (Dosage And Administration)

Two data tables listing recommended dosage regimens for prevention of nausea and vomiting with ondansetron. The first table covers adult dosing for indications including highly emetogenic cancer chemotherapy, moderately emetogenic cancer chemotherapy, radiotherapy, and postoperative settings, detailing specific dosing schedules and timing. The second table provides pediatric dosing recommendations for moderately emetogenic cancer chemotherapy for different age groups, specifying doses and timing relative to chemotherapy administration.*

FDA Label Image

Structure (Structure)

Chemical structure of ondansetron hydrochloride dihydrate, the active ingredient in ONDANSETRON 4 mg film-coated tablet, showing the molecular arrangement including aromatic rings and nitrogen atoms.*

* 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.