Ondansetron Injection, Solution
Product Images NDC 51662-1469

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Ondansetron (NDC 51662-1469). 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.

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Adverse 2 (Adverse 2)

A data table comparing adverse reactions in patients receiving Ondansetron Injection 4 mg Intravenous versus a placebo group. It lists specific reactions including headache, drowsiness/sedation, injection site reaction, fever, cold sensation, pruritus, and paresthesia, with corresponding patient counts and percentages for each group.*

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Adverse 1 (Adverse 1)

A data table comparing the incidence of adverse reactions in adult patients among three groups: Ondansetron Injection (0.15 mg/kg × 3, n=419), Metoclopramide (n=156), and Placebo (n=34). The adverse reactions listed are Diarrhea, Headache, and Fever, with respective percentages for each group.*

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Clinical P 1 (Clinical P 1)

A data table presenting pharmacokinetic parameters for ondansetron injection, solution at 2 mg/mL by age group. It includes age groups (19–40, 61–74, ≥75 years), sample size (n), peak plasma concentrations (ng/mL), mean elimination half-life (hours), and plasma clearance (L/h/kg).*

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Clinical P 2 (Clinical P 2)

A data table comparing pharmacokinetic parameters in two groups: pediatric cancer patients aged 4 to 18 years (N=21) and population PK patients aged 1 month to 48 months (N=115). The table lists geometric mean values for clearance (CL) and volume of distribution at steady state (Vdss), and mean half-life (T½) in hours for ondansetron injection solution.*

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Clinical P 3 (Clinical P 3)

A data table presenting pharmacokinetic parameters of Ondansetron Injection, Solution 2 mg/mL in pediatric surgery patients across different age groups. It includes subject age groups, sample sizes (N), and geometric mean values for clearance (CL), volume of distribution at steady state (Vdss), and mean half-life (T½) in hours.*

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Clinical S 1 (Clinical S 1)

A data table comparing treatment responses between Ondansetron Injection (0.15 mg/kg × 3) and placebo groups, each with 14 patients. It presents number of emetic episodes, median emetic episode counts, median time to first emetic episode in hours, median nausea scores, and global satisfaction scores, along with associated P values for each category.*

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Clinical S 3 (Clinical S 3)

A data table comparing treatment responses between Ondansetron Injection (0.15 mg/kg × 3) and placebo groups, each with 10 patients. It displays results for emetic episodes, median number of episodes, median time to first episode, median nausea scores, and global satisfaction with nausea and vomiting control, including P values indicating statistical significance.*

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Clinical S 4 (Clinical S 4)

A data table comparing the effectiveness of Ondansetron 4 mg intravenous versus placebo in two studies. It reports numbers of patients, emetic episodes, treatment responses over a 24-hour postoperative period, and nausea assessments, including percentages and P values for statistical significance.*

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Clinical S 5 (Clinical S 5)

A data table displaying treatment response over 24 hours comparing Ondansetron and placebo across three studies. It lists number of patients, percentage with 0 emetic episodes, and failure rates for each group, along with nausea assessments and P values indicating statistical significance.*

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Clinical S 6 (Clinical S 6)

A data table presenting clinical study results comparing Ondansetron 4 mg intravenous injection with placebo. It includes the number of patients, treatment response 24 hours after drug administration, emetic episodes, median time to first emetic episode, and mean nausea scores over a 24-hour postoperative period for two separate studies.*

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Clinical S 7 (Clinical S 7)

A data table presenting treatment response over 24 hours comparing Ondansetron and placebo groups. It includes number of patients, percentage with 0 emetic episodes, and failure rates, along with associated P values indicating statistical significance.*

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Dosage (Dosage)

A dosing and administration table for ONDANSETRON injection, solution 2 mg/mL from HF Acquisition Co LLC. It outlines recommended single doses and administration instructions for adults and pediatric patients, including intravenous and intramuscular routes, with timing relative to anesthesia and surgery.*

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How Supplied (How Supplied)

A data table presenting unit of sale and concentration for ondansetron injection, solution. It lists NDCs 0409-4755-03 and 0409-4759-01, with packaging of 25 single-dose vials of 2 mL each and 1 multiple-dose vial of 20 mL respectively. Both have a concentration of 2 mg/mL.*

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Logo (Logo)

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Serialized Labeling (Serialized Labeling)

Ondansetron Injection, USP 4 mg/2 mL (2 mg/mL) clear solution in a 2 mL single-use vial with a green cap. Label includes manufacturer Hospira, Inc., and distribution by HF Acquisition Co LLC. The vial label warns to protect from light and references the product as prescription only. A barcode and additional regulatory numbers are visible on an adjacent label.*

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Structure (Structure)

Chemical structure of ondansetron hydrochloride dihydrate, the active ingredient in ONDANSETRON injection, solution 2 mg/mL by HF Acquisition Co LLC, DBA HealthFirst. The diagram depicts the molecular arrangement including rings, bonds, and attached functional groups.*

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Vial Label Option 1 (Vial Label Option 1)

Label for Ondansetron Injection, USP 4 mg/2 mL (2 mg/mL) single-dose vial. The label includes dosage form as injection solution, single-dose vial volume of 2 mL, and manufacturer HOSPIRA, Inc., Lake Forest, IL. It notes storage instruction to protect from light and states Rx only with a barcode and NDC 0409-4755-18.*

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Vial Labe Option 3 (Vial Label Option 3)

Label for Ondansetron Injection, USP, showing a 2 mL single-use vial with a strength of 4 mg per 2 mL (2 mg/mL). The label includes the statement 'PROTECT FROM LIGHT' and notes the manufacturer as Hospira, Inc., Lake Forest, IL. It also displays the NDC number 0409-4755-18 and advises 'Rx only.' Additional barcode and batch detail area are present.*

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Vial Label Option 2 (Viallabel Option 2)

Label of Ondansetron Injection, USP showing a 2 mL single-dose vial containing 4 mg/2 mL (2 mg/mL) solution. The label includes a barcode and states 'Rx only,' distributed by Hospira, Inc., Lake Forest, IL, USA.*

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Clinical S 2 (Clinical S 2)

A data table comparing the efficacy and safety outcomes of Ondansetron Injection (0.15 mg/kg × 3) and Metoclopramide (2 mg/kg × 6) in patients. It includes patient numbers, treatment responses by emetic episodes, statistical comparisons, median number and time to first emetic episode, global satisfaction scores, and incidence of acute dystonic reactions and akathisia, with associated p-values.*

* 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.