Irinotecan Hydrochloride Injection
Product Images NDC 50742-402

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Irinotecan Hydrochloride (NDC 50742-402). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ingenus Pharmaceuticals, Llc, 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

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Chemical structure of Irinotecan Hydrochloride, showing its complex molecular arrangement including rings and functional groups as well as the presence of HCl and three water molecules (3H2O).*

FDA Label Image

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A Kaplan-Meier survival curve comparing First-Line Irinotecan/5-FU/LV versus 5-FU/LV alone over months. The y-axis represents survival probability, and the x-axis shows time in months up to 42 months. The graph indicates statistically significant differences with a p-value less than 0.05 by log-rank test.*

FDA Label Image

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A survival curve chart comparing the probability of survival over months between two treatment groups: Irinotecan/5-FU/LV and 5-FU/LV. The chart shows time in months on the x-axis and probability on the y-axis, with the Irinotecan combination group demonstrating a higher survival probability over time. A p-value of less than 0.05 is noted, indicating statistical significance.*

FDA Label Image

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A Kaplan-Meier survival curve comparing second-line Irinotecan versus Best Supportive Care (BSC) in Study 7. The y-axis shows survival probability, and the x-axis shows time in months up to 21. The graph plots two survival trajectories indicating higher survival for Irinotecan over BSC, with statistical significance (p=0.0001). Summary statistics include median follow-up and median survival months for each group.*

FDA Label Image

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A survival curve comparing second-line Irinotecan and infusion 5-FU treatments over time in months. The y-axis shows survival probability, while the x-axis shows months up to 21. The graph includes median follow-up and median survival for each treatment group, with Irinotecan having a higher survival probability over time compared to 5-FU. The p-value of 0.035 is noted from a log-rank test.*

FDA Label Image

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Label of Irinotecan Hydrochloride Injection, USP 40 mg/2 mL (20 mg/mL) single-dose vial for intravenous use. The label highlights that the product is a cytotoxic agent requiring dilution before use. It is manufactured by Ingenus Pharmaceuticals, LLC, Orlando, FL, with storage instructions and barcode visible.*

FDA Label Image

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Label for Irinotecan Hydrochloride Injection, USP 100 mg/5 mL (20 mg/mL) intravenous injection in a 5 mL single-dose vial. The label includes dosage instructions, caution of cytotoxicity, storage conditions (20 to 25°C), and manufacturer information for Ingenus Pharmaceuticals, LLC, Orlando, FL. Lot number, serial number, and expiration date fields are blank.*

FDA Label Image

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Carton label for Irinotecan Hydrochloride Injection, USP 40 mg/2 mL (20 mg/mL) single-dose vial by Ingenus Pharmaceuticals, LLC. The label states the product is for intravenous use only and must be diluted before use, with a caution noting it as a cytotoxic agent. Storage instructions and manufacturer details are included, along with active ingredient concentration and other non-medicinal ingredients.*

FDA Label Image

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Packaging label for Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL) single-dose vial. The label indicates the product is for intravenous use only and must be diluted before use, with a caution for cytotoxicity. It is manufactured for Ingenus Pharmaceuticals, LLC, Orlando, FL, and made in Switzerland. The label includes storage instructions and a barcode.*

* 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.