Irinotecan Hydrochloide Injection
Product Images NDC 68083-381

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Irinotecan Hydrochloide (NDC 68083-381). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Gland Pharma Limited, 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 Spl Carton 2 mL

Packaging label for Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL) intravenous injection by Gland Pharma Limited. The label specifies a 2 mL single-dose vial, with warnings for dilution before use and cytotoxic agent caution. Storage instructions and a red warning for damaged or leaking contents are included.*

FDA Label Image

Irinotecan Spl Carton 5 mL

Packaging label for Irinotecan Hydrochloride Injection, USP 100 mg/5 mL (20 mg/mL) intravenous injection, single-dose vial. The label includes storage instructions, dilution requirements, and warnings about cytotoxicity. Manufactured by Gland Pharma Limited, Visakhapatnam, India. The label shows active ingredient details, barcode, and NDC 68083-382-01.*

FDA Label Image

Irinotecan Spl Container 2 mL

Label for Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL) single dose vial for intravenous use. Manufactured by Gland Pharma Limited, India. The label includes dosage warnings, barcode, and space for lot and expiration dates.*

FDA Label Image

Irinotecan Spl Container 5 mL

Label for Irinotecan Hydrochloride Injection, USP, with a strength of 100 mg/5 mL (20 mg/mL) in a 5 mL single-dose vial. The label indicates it is for intravenous use only, must be diluted before use, and cautions it is a cytotoxic agent. Manufactured by Gland Pharma Limited in India, storage instructions specify keeping at controlled room temperature (25°C/68°F to 77°F) and protecting from freezing and light.*

FDA Label Image

Irinotecan Spl Figure 1

A Kaplan-Meier curve chart showing probability over time in months for two treatment groups: Irinotecan/5-FU/LV and 5-FU/LV. The y-axis represents probability from 0.0 to 1.0, and the x-axis represents months from 0 to 42. The chart includes a p-value of less than 0.05 from a log-rank test.*

FDA Label Image

Irinotecan Spl Figure 2

A Kaplan-Meier survival curve comparing the probability of survival over months between two treatment groups: Irinotecan/5-FU/LV and 5-FU/LV. The y-axis represents survival probability, and the x-axis shows time in months up to 30 months. The graph includes a p-value indication (p<0.05) suggesting statistical significance between the groups.*

FDA Label Image

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

A Kaplan-Meier survival probability curve comparing Irinotecan hydrochloride to BSC (Best Supportive Care) over 21 months. The x-axis represents months and the y-axis shows probability. The graph shows higher survival probability for Irinotecan compared to BSC, with median follow-up of 13 months for Irinotecan and 9.2 months for BSC. A p-value of 0.0001 indicates statistical significance.*

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 treatments: Irinotecan and 5-FU. The y-axis represents probability from 0.0 to 1.0, and the x-axis shows time in months from 0 to 21. The curve for Irinotecan shows higher survival probability than 5-FU. Median follow-up and median survival are noted for each treatment group, with a log-rank test p-value of 0.035.*

FDA Label Image

Irinotecan-spl-structure (Irinotecan Spl Structure)

Chemical structure of Irinotecan Hydrochloride. The diagram shows the molecular structure with labeled atoms and chemical groups, including indications of HCl and 3 H2O components.*

* 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.