Irinotecan Hydrochloride Injection
Product Images NDC 70700-170

9 FDA label images from Xiromed Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Irinotecan Hydrochloride (NDC 70700-170). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xiromed 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

2ml-carton (2ml Carton)

2ml-carton (2ml Carton)
Box label for Irinotecan Hydrochloride Injection, USP 40 mg/2 mL (20 mg/mL) by Xiromed LLC. The sterile, aqueous intravenous injection is supplied in a 2 mL single dose vial. The label includes warnings to dilute before use, storage instructions, and a caution that the product is a cytotoxic agent. Additional details include inactive ingredients, manufacturing information, and barcode.*
FDA Label Image

5ml-carton (5ml Carton)

5ml-carton (5ml Carton)
Packaging label for Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL) for intravenous use, labeled as a cytotoxic agent. The label shows a 5 mL single-dose vial, with dilution required before use. Manufactured for Xiromed LLC, Florham Park, NJ, product of India. Storage instructions include storing at 20 to 25°C and protecting from light and freezing.*
FDA Label Image

Irinotecan-container-label-100mg (Irinotecan Container Label 100mg)

Irinotecan-container-label-100mg (Irinotecan Container Label 100mg)
Label for Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL) sterile aqueous solution for intravenous use. The label indicates a 5 mL single dose vial, highlights storage instructions (store at 20° to 25°C and protect from light and freezing), and cautions that the product is a cytotoxic agent. The labeler is Xiromed LLC, with manufacturing information also noted.*
FDA Label Image

Irinotecan-container-label-40mg (Irinotecan Container Label 40mg)

Irinotecan-container-label-40mg (Irinotecan Container Label 40mg)
Label for Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL concentration (20 mg/mL), manufactured by Xiromed LLC. The label indicates intravenous use only, single-dose vial, with a warning about cytotoxicity. It includes usage instructions to dilute before use and has a barcode and manufacturer details.*
FDA Label Image

Irinotecan Spl Figure 1

Irinotecan Spl Figure 1
A Kaplan-Meier survival curve graph comparing the probability of survival over time in months between two treatments, Irinotecan/5-FU/LV and 5-FU/LV alone. The vertical axis shows probability from 0 to 1, and the horizontal axis shows time in months up to 42. A statistical significance indicator (p<0.05) is noted.*
FDA Label Image

Irinotecan Spl Figure 2

Irinotecan Spl Figure 2
A Kaplan-Meier survival curve chart showing the probability of survival over a 30-month period for two treatment groups: Irinotecan/5-FU/LV and 5-FU/LV. The vertical axis represents survival probability, and the horizontal axis represents time in months. The chart includes a significance indicator (p<0.05) for difference between groups.*
FDA Label Image

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

Irinotecan-spl-figure-3 (Irinotecan Spl Figure 3)
Kaplan-Meier survival curve comparing the probability of survival over time in months between patients treated with Irinotecan and those receiving Best Supportive Care (BSC). The graph shows higher survival probability for Irinotecan, with patient numbers and median follow-up times noted for each group.*
FDA Label Image

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

Irinotecan-spl-figure-4 (Irinotecan Spl Figure 4)
A Kaplan-Meier survival probability chart comparing Irinotecan and 5-FU treatments over 21 months. The x-axis represents time in months and the y-axis shows probability from 0 to 1. The chart includes data on the number of subjects and median follow-up times for each treatment, with a p-value of 0.035 from a log-rank test assessing statistical significance between the two survival curves.*
FDA Label Image

Irinotecan-spl-structure (Irinotecan Spl Structure)

Irinotecan-spl-structure (Irinotecan Spl Structure)
Chemical structure of irinotecan hydrochloride, displaying its molecular framework including a quinoline moiety and associated chemical groups, with annotations indicating the presence of hydrochloride (HCl) and three water molecules (3 H2O).*

* 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.