Irinotecan Hydrochloride Injection
Product Images NDC 16714-027

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Irinotecan Hydrochloride (NDC 16714-027). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rx 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

Irinotecan-carton-labeling-100mg (Irinotecan 100mg 5ml Carton)

Packaging label for Irinotecan Hydrochloride Injection, USP 100 mg/5 mL (20 mg/mL) by Northstar Rx LLC. The label indicates it is for intravenous use only, must be diluted before use, and is a cytotoxic agent. The product is supplied as a 5 mL single dose vial of sterile aqueous solution. Storage instructions include room temperature (20° to 25°C) and protection from light and freezing. The label includes manufacturing information from Gland Pharma Ltd, India, and a barcode.*

FDA Label Image

Irinotecan-container-label-100mg (Irinotecan 100mg 5ml Vial)

Label for Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL) for intravenous use, single dose 5 mL vial. The sterile aqueous solution is marked for dilution before use and labeled as a cytotoxic agent. Manufactured by Gland Pharma Ltd. and labeled for Northstar Rx LLC.*

FDA Label Image

Irinotecan-carton-labeling-40mg (Irinotecan 40mg 2ml Carton)

Packaging label for Irinotecan Hydrochloride Injection, USP 40 mg/2 mL (20 mg/mL) intravenous injection by Northstar Rx LLC. The carton indicates a 2 mL single dose vial and includes storage, dilution, and cytotoxic agent caution information. Manufactured by Gland Pharma Ltd, India.*

FDA Label Image

Irinotecan-container-label-40mg (Irinotecan 40mg 2ml Vial)

Label for Irinotecan Hydrochloride Injection, USP with strength 40 mg/2 mL (20 mg/mL) in a 2 mL single-dose vial. Designed for intravenous use only and must be diluted before use. The label includes caution that it is a cytotoxic agent. Manufactured for Northstar Rx LLC, Memphis, TN, and by Gland Pharma Ltd, Visakhapatnam, India. Includes NDC code 16714-027-01 and barcode.*

FDA Label Image

Irinotecan Spl Figure 1

A Kaplan-Meier survival probability curve comparing Irinotecan/5-FU/LV versus 5-FU/LV over a time period of up to 42 months. The y-axis represents probability from 0 to 1, and the x-axis represents months. The graph includes a significance indication with p<0.05 by log-rank test.*

FDA Label Image

Irinotecan Spl Figure 2

A Kaplan-Meier survival curve comparing two treatment groups: Irinotecan/5-FU/LV and 5-FU/LV. The y-axis shows probability ranging from 0.0 to 1.0, and the x-axis shows time in months from 0 to 30. The survival probability is higher for the Irinotecan/5-FU/LV group over time, with a significant difference indicated by p<0.05 from a log-rank test.*

FDA Label Image

Irinotecan-spl-figure-3 (Irinotecan Spl Figure 3)

A Kaplan-Meier survival curve comparing probability over months between two groups: Irinotecan and BSC (Best Supportive Care). The graph plots survival probability on the y-axis against months on the x-axis, showing higher survival probability for Irinotecan over time. The chart includes median follow-up times and sample sizes for each group and a statistical p-value from a log-rank test.*

FDA Label Image

Irinotecan-spl-figure-4 (Irinotecan Spl Figure 4)

A Kaplan-Meier survival curve comparing the probability of survival over 21 months between two treatment groups labeled Irinotecan and 5-FU. The graph includes sample sizes (127 for Irinotecan, 129 for 5-FU), median follow-up times (15 months for Irinotecan, 8.5 months for 5-FU), and a p-value of 0.035 indicating statistical comparison. The x-axis displays time in months and the y-axis shows survival probability from 0 to 1.*

FDA Label Image

Irinotecan-spl-structure (Irinotecan Spl Structure)

Chemical structure of Irinotecan Hydrochloride showing its molecular composition including hydrochloride (HCl) and three water molecules (3 H2O). The diagram highlights the arrangement of rings, functional groups, and side chains characteristic of the compound.*

* 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.