Ondansetron Injection
Product Images NDC 51662-1245

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 51662-1245). 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

Vial Label (1000480 0641 6078 01 Ondansetron Vial)

ONDANSETRON Injection, USP 4 mg/2 mL (2 mg/mL) single dose vial label. The label states it is for intravenous (IV) or intramuscular (IM) injection, with a 2 mL volume. It instructs to protect from light and includes manufacturer information: West-Ward, a part of HF Acquisition Co LLC, DBA HealthFirst. The label also shows the NDC 0641-6078-01 and space for lot number and expiration date.*

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Adverse Tabel 1 (Adverse 1)

A data table showing the number of adult patients experiencing adverse reactions (Diarrhea, Headache, Fever) to Ondansetron Injection (0.15 mg/kg x 3, n=419), Metoclopramide (n=156), and Placebo (n=34). Percentages of patients with each reaction are listed for each treatment group.*

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Adverse Table 2 (Adverse 2)

A data table presenting adverse reactions observed in a study comparing Ondansetron Injection 4 mg Intravenous and a placebo, both with 547 subjects. The table lists adverse reactions such as headache, drowsiness/sedation, injection site reaction, fever, cold sensation, pruritus, and paresthesia, including the number and percentage of subjects affected in each group.*

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Tabel 1 (Clinical 1)

Pharmacokinetic data table presenting Peak Plasma Concentration (ng/mL), Mean Elimination Half-life (hours), and Plasma Clearance (L/h/kg) of ondansetron injection stratified by age-group (19-40, 61-74, ≥75 years) with corresponding sample size (n).*

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Tabel 2 (Clinical 2)

A data table showing pharmacokinetic parameters of ondansetron for two subject groups: Pediatric cancer patients aged 4 to 18 years (N=21) and population PK patients aged 1 month to 48 months (N=115). Parameters listed include clearance (CL, L/h/kg), volume of distribution at steady state (Vdss, L/kg), and half-life (t½, hours), with geometric mean and mean values provided.*

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Tabel 3 (Clinical 3)

A data table presenting pharmacokinetic parameters for Ondansetron in pediatric surgery patients across three age groups: 3 to 12 years, 5 to 24 months, and 1 month to 4 months. The table shows the number of subjects (N), clearance (CL) in L/h/kg, volume of distribution at steady state (Vdss) in L/kg, and mean half-life (t1/2) in hours for each group.*

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1 (Clinical Studies 1)

A data table comparing treatment responses between Ondansetron Injection (0.15 mg/kg x 3) and placebo groups, showing numbers and percentages of emetic episodes, median numbers and times for emetic events, median nausea scores, and global satisfaction scores, with associated p-values indicating statistical analysis results.*

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2 (Clinical Studies 2)

A data table comparing efficacy and safety outcomes between Ondansetron Injection 0.15 mg/kg x 3 and Metoclopramide 2 mg/kg x 6. It includes patient numbers, treatment responses by emetic episodes, median number and time to first emetic episode, global satisfaction scores, and incidence of acute dystonic reactions and akathisia, with associated P values.*

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3 (Clinical Studies 3)

A data table comparing Ondansetron Injection (0.15 mg/kg x 3) versus placebo in treatment response among 10 patients each. It lists outcomes including number of emetic episodes, median emetic episodes, median time to first emetic episode, median nausea scores, and patient satisfaction scores, with corresponding P values indicating statistical significance.*

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4 (Clinical Studies 4)

A data table comparing the treatment response of Ondansetron 4 mg intravenous versus placebo over a 24-hour postoperative period in two studies. It details the number of emetic episodes, number of patients, and nausea assessments including percentages of patients with zero, one, or more than one emetic episode, along with P values indicating statistical significance.*

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5 (Clinical Studies 5)

A data table comparing treatment response over 24 hours between Ondansetron and placebo groups across three studies, including numbers and percentages of patients with zero emetic episodes and treatment failure. The table also includes nausea assessments and associated p-values indicating statistical significance of the comparisons.*

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6 (Clinical Studies 6)

A data table comparing Ondansetron 4 mg intravenous with placebo in two studies. It displays emetic episodes, patient numbers, treatment responses at 24 hours post-study drug (including zero, one, or more emetic episodes), median time to first emetic episode in minutes, and mean nausea scores over a 24-hour postoperative period. P values for statistical significance between Ondansetron and placebo are also shown.*

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7 (Clinical Studies 7)

A data table comparing treatment response over 24 hours between Ondansetron and Placebo groups. It shows the number of patients in each group and the counts and percentages of those with zero emetic episodes and treatment failures, along with P values for statistical significance.*

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Dosage Tabel 1 (Dosage Tabel 1)

A dosage and administration table for ondansetron injection showing recommended single doses and administration instructions by patient population. It includes dosing guidelines for adults, pediatric patients over 12 years, pediatric patients 1 month to 12 years over 40 kg, and pediatric patients 1 month to 12 years 40 kg or less, with intravenous or intramuscular routes and timing related to anesthesia or postoperative conditions.*

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Structure (Structure)

Chemical structure of ondansetron hydrochloride dihydrate, depicted with its fused ring system and functional groups, representing the active ingredient of ONDANSETRON injection 2 mg/mL by HF Acquisition Co LLC, DBA HealthFirst.*

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Serialized Label (Serialized 51662 1245 1 Ondansetron)

Ondansetron Injection USP 4 mg/2 mL clear glass vial with blue cap and a white label showing the product name and strength. Next to the vial is a white label with barcodes, identifiers, and manufacturer information stating distribution by HF Acquisition Co LLC, Mukilteo, WA.*

* 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.