Irinotecan Hydrochloride Injection, Solution
Product Images NDC 55150-353

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Irinotecan Hydrochloride (NDC 55150-353). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Eugia Us 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

First-line Irinotecan/5-fu/lv Vs 5-fu/lv Study 1 (Irinotecan Fig1)

A Kaplan-Meier survival curve chart comparing two treatment groups labeled Irinotecan/5-FU/LV and 5-FU/LV over a time period up to 42 months. The y-axis represents probability, and the x-axis represents months. A statistical significance notation indicates p<0.05 using a log-rank test.*

FDA Label Image

Irinotecan-figure10 (Irinotecan Fig10)

Box packaging label for Irinotecan HCl Injection, USP, 20 mg/mL (300 mg per 15 mL) intravenous solution. The label states it is for intravenous use only, must be diluted before use, cautions as a cytotoxic agent, and is supplied as a 15 mL single-dose vial. Distributed by AuroMedics Pharma LLC and made in India, with storage instructions and dilution warnings included.*

FDA Label Image

Irinotecan Fig11

Label for Irinotecan HCl Injection, USP 20 mg/mL (500 mg per 25 mL) solution for intravenous use, supplied in a 25 mL single-dose vial. The product is sterile and must be diluted before use. Manufactured in India for AuroMedics Pharma LLC, East Windsor, NJ. Included are storage instructions and warnings about light protection and cytotoxicity.*

FDA Label Image

Irinotecan Fig12

Packaging label for Irinotecan HCl Injection, USP 500 mg per 25 mL (20 mg/mL) intravenous injection by Auromedics. The label shows a single-dose 25 mL vial, contains the active ingredient irinotecan hydrochloride trihydrate, and indicates it is sterile. It includes warnings such as cytotoxic agent and must be diluted before use. Storage and distributor information (AuroMedics Pharma LLC) are also present.*

FDA Label Image

First-line Irinotecan/5-fu/lv Vs 5-fu/lv Study 2 (Irinotecan Fig2)

A Kaplan-Meier survival curve comparing the probability over time in months between two treatment groups: Irinotecan/5-FU/LV and 5-FU/LV. The plot shows a higher probability of survival in the Irinotecan/5-FU/LV group over approximately 27 months, with a p-value less than 0.05 indicating statistical significance.*

FDA Label Image

Figure 3. Survival Second-line Irinotecan Vs Best Supportive Care (bsc) Study 7 (Irinotecan Fig3)

A Kaplan-Meier survival plot comparing the probability of survival over months between Irinotecan and BSC (best supportive care) groups. The y-axis shows probability, and the x-axis shows time in months up to 21 months. The graph includes median follow-up times and a p-value indicating statistical significance of the difference in survival between groups.*

FDA Label Image

Figure 4. Survival Second-line Irinotecan Vs Infusion 5-fu Study 8 (Irinotecan Fig4)

A survival probability plot comparing Irinotecan and 5-FU treatments over 21 months. The y-axis shows probability, and the x-axis shows months. Two curves illustrate declining survival probabilities, with Irinotecan showing higher probability than 5-FU. The graph includes median follow-up time (15 months) and p-value (0.035) from a log-rank test.*

FDA Label Image

Irinotecan-figure5 (Irinotecan Fig5)

Label for Irinotecan HCl Injection, USP 40 mg per 2 mL (20 mg/mL), intravenous injection solution in a 2 mL single dose vial. The label includes a caution for cytotoxic agent and indicates the drug is for prescription use only. Manufactured in India for AuroMedics Pharma LLC, E. Windsor, NJ.*

FDA Label Image

Irinotecan-figure6 (Irinotecan Fig6)

Packaging label for Irinotecan HCl Injection, USP, 40 mg per 2 mL (20 mg/mL) aqueous solution for intravenous use. The label indicates it is a cytotoxic agent, provided in a single-dose 2 mL vial. Labeler is Auromedics (distributed by AuroMedics Pharma LLC). Instructions include dilution before use, storage conditions, and warnings to discard unused portions.*

FDA Label Image

Irinotecan-figure7 (Irinotecan Fig7)

Label for Irinotecan HCl Injection, USP, 20 mg/mL (100 mg per 5 mL), an intravenous cytotoxic agent. The label indicates single-dose vial of 5 mL, manufactured in India for AuroMedics Pharma LLC, with storage instructions to protect from light and freezing. Includes barcode and NDC 55150-353-01.*

FDA Label Image

Irinotecan-figure8 (Irinotecan Fig8)

Packaging label for Irinotecan HCl Injection, USP 100 mg per 5 mL (20 mg/mL) by Auromedics. This sterile aqueous solution is for intravenous use only, supplied as a 5 mL single-dose vial. The label includes warnings about dilution before use, cytotoxicity, storage instructions, and distributor information for AuroMedics Pharma LLC.*

FDA Label Image

Irinotecan-figure9 (Irinotecan Fig9)

Label for Irinotecan HCl Injection, USP, 300 mg per 15 mL (20 mg/mL) solution for intravenous use. The product is a 15 mL single dose vial labeled as a cytotoxic agent. It is sterile, aqueous, and includes storage instructions to protect from light and freezing. Manufactured in India for AuroMedics Pharma LLC, E. Windsor, NJ.*

FDA Label Image

Chemical Structure (Irinotecan Str)

Chemical structure of Irinotecan Hydrochloride, showing its molecular arrangement including functional groups and atoms, with annotations for hydrochloride (HCl) and trihydrate (3 H2O) forms.*

* 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.