Irinotecan Hydrochloride Injection, Solution
Product Images NDC 67184-0512

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Irinotecan Hydrochloride (NDC 67184-0512). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Qilu Pharmaceutical Co., Ltd., 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

15ml-carton (15ml Carton)

Label for Irinotecan Hydrochloride Injection, USP, 300 mg/15 mL (20 mg/mL) solution for intravenous use. The product is a single-dose vial, with the label showing usage cautions, storage instructions, and manufacturer Qilu Pharmaceutical Co., Ltd., Haikou, China. The label notes the product is cytotoxic and provides details on active ingredient concentration and dilution requirements.*

FDA Label Image

15ml-container (15ml Container)

Label for Irinotecan Hydrochloride Injection, USP, 300 mg/15 mL (20 mg/mL) solution for intravenous injection. The label states it is for intravenous use only and must be diluted before use. It includes storage instructions and manufacturing details from Qilu Pharmaceutical (Hainan) Co., Ltd. The label features a barcode and a caution that the product is a cytotoxic agent.*

FDA Label Image

2ml-carton (2ml Carton)

Package label for Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL) solution for intravenous use. The label notes single-dose use with disposal instructions, cytotoxic caution, storage conditions, and manufacturer Qilu Pharmaceutical Co., Ltd., China. It includes NDC 67184-0511-1 and standard warnings about use and dosage dilution.*

FDA Label Image

2ml-container (2ml Container)

Label for Irinotecan Hydrochloride Injection USP, 40 mg/2 mL (20 mg/mL) solution for intravenous use. The label notes single-dose use, cytotoxic agent caution, manufacture by Qilu Pharmaceutical Co., Ltd., Haikou, China, and includes lot and expiration date fields.*

FDA Label Image

5ml-carton (5ml Carton)

Label for Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL) single-dose solution for intravenous use by Qilu Pharmaceutical Co., Ltd. The label includes storage instructions, warnings for cytotoxic use, and directions to discard unused portions. Lot and expiration date fields are blank. The product is indicated for single-dose use with caution regarding light and freezing exposure.*

FDA Label Image

5ml-container (5ml Container)

Label for Irinotecan Hydrochloride Injection, USP 20 mg/mL (100 mg/5 mL) by Qilu Pharmaceutical Co., Ltd. The label indicates the product is for intravenous use only, must be diluted before use, and is a cytotoxic agent. Storage instructions note temperatures between 20° to 25°C with permitted excursions. Includes lot and expiration date fields and a barcode.*

FDA Label Image

Figure 1

A survival curve chart titled 'First-Line Irinotecan/5-FU/LV vs 5-FU/LV Study 1' comparing probability of survival over months. Two survival curves represent Irinotecan/5-FU/LV and 5-FU/LV treatments. The x-axis shows time in months (0 to 42), and the y-axis shows survival probability (0 to 1.0). A statistically significant difference (p<0.05) is indicated.*

FDA Label Image

Figure 2

A survival curve chart comparing First-Line Irinotecan/5-FU/LV versus 5-FU/LV alone from Study 2. The x-axis represents time in months up to 30, and the y-axis represents survival probability from 0 to 1. Two lines show survival probability over time for Irinotecan/5-FU/LV and 5-FU/LV groups, with a noted statistical significance (p<0.05) by log-rank test.*

FDA Label Image

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

A survival curve comparing Second-Line Irinotecan versus Best Supportive Care (BSC) in Study 7. The graph plots probability of survival on the vertical axis against months on the horizontal axis, showing higher survival probability over time with Irinotecan compared to BSC. The chart includes sample sizes, median follow-up duration (13 months), and median survival times for Irinotecan (9.2 months) and BSC (6.5 months).*

FDA Label Image

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

A survival curve graph comparing the probability of survival over time (months) between Irinotecan and infusion 5-FU in a second-line study. The graph shows survival probabilities on the y-axis (0 to 1) and time in months on the x-axis (0 to 21). Two curves represent Irinotecan and 5-FU, with survival probabilities decreasing over time. The graph includes median follow-up and median months for each treatment group, with statistical significance noted (p=0.035).*

FDA Label Image

Irinotecan Hydrochloride Structural Formula (Irinotecan Hydrochloride)

Chemical structure diagram of irinotecan hydrochloride showing its molecular components, including rings, chains, and functional groups, with annotations indicating 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.