Irinotecan Hydrochloride
Product Images NDC 59923-715

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Irinotecan Hydrochloride (NDC 59923-715). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Areva Pharmaceuticals, Inc., 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

Carton Label (100mg Carton Label)

Packaging label for Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL) single-dose vial. The label includes warnings, dosing instructions, and storage conditions. It also displays the NDC 59923-715-05 and notes that the product is for intravenous use only and is a cytotoxic agent. Distributed by Areva Pharmaceuticals, Inc., made in India.*

FDA Label Image

Unit Label (100mg Vial Label)

Irinotecan Hydrochloride Injection, USP 100 mg/5 mL (20 mg/mL) label for a 5 mL single-dose vial. Contains irrinotecan hydrochloride, USP 20 mg, sorbitol powder 45 mg, and other ingredients. Labeled for intravenous use only with a caution for cytotoxic agent. Distributed by Areva Pharmaceuticals, Inc. in Georgetown, IN. The vial is sterile aqueous solution, stored between 20° to 25°C.*

FDA Label Image

300mg Carton Label

Packaging label for Irinotecan Hydrochloride Injection, USP, 300 mg/15 mL (20 mg/mL) by Areva Pharmaceuticals, Inc. The label states it is for intravenous use only in a single-dose 15 mL vial, highlights a cytotoxic agent caution, and includes storage instructions at 20-25°C. It also features a barcode, NDC 59923-716-15, and warnings for dilution, damage, and disposal instructions.*

FDA Label Image

300mg Vial Label

Label for Irinotecan Hydrochloride Injection, USP 300 mg/15 mL (20 mg/mL) by Areva Pharmaceuticals, Inc. This sterile, aqueous injectable solution comes in a 15 mL single-dose vial. The label indicates cytotoxicity caution, intended for intravenous use only, and includes storage instructions and manufacturer information.*

FDA Label Image

Carton Label (40mg Carton Label)

Packaging label for Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL) by Areva Pharmaceuticals, Inc. The label indicates it is for intravenous use only and is a single-dose 2 mL vial. It includes warnings about cytotoxicity, storage instructions to protect from freezing and light, and mentions the product is sterile and aqueous. The label also displays the NDC 59923-714-02.*

FDA Label Image

Unit Label (40mg Vial Label)

Label for Irinotecan Hydrochloride Injection USP, 40 mg/2 mL (20 mg/mL), a sterile aqueous solution for intravenous use. The single-dose vial contains 2 mL. Distributed by Areva Pharmaceuticals, Inc. The label includes storage instructions and cautions that it is a cytotoxic agent.*

FDA Label Image

Structure (Chemical Structure)

Chemical structure of Irinotecan Hydrochloride shown as a 2D molecular diagram with labeled atoms and bonds, including the hydrochloride and hydrate components. The image illustrates the detailed arrangement of rings, functional groups, and substituents typical for this molecule.*

FDA Label Image

Figure 3 (Figure 3)

A survival probability Kaplan-Meier curve comparing Irinotecan Hydrochloride treatment versus BSC (best supportive care) over approximately 21 months. The graph includes median follow-up and median survival in months for both groups, illustrating differences in survival probability over time.*

FDA Label Image

Figure 4 (Figure 4)

A Kaplan-Meier survival curve comparing the probability of survival over months for Irinotecan versus 5-FU treatments. The graph shows median follow-up and median survival times for both groups, with a p-value from a log-rank test indicating statistical comparison.*

FDA Label Image

Figure1

A survival curve chart comparing First-line Irinotecan/5-FU/LV versus 5-FU/LV alone over months. The y-axis shows survival probability from 0.0 to 1.0, and the x-axis shows time in months up to 42. The graph displays two survival probability lines with a noted statistic p<0.05, indicating statistical comparison between the two treatments in Study 1.*

FDA Label Image

Figure2

A survival curve chart comparing first-line Irinotecan/5-FU/LV versus 5-FU/LV alone in Study 2. The vertical axis represents survival probability from 0 to 1, and the horizontal axis shows time in months from 0 to 30. Two curves illustrate survival trends, with a statistical significance noted as p<0.05 by log-rank test.*

* 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.