Irinotecan Hydrochloride Injection
Product Images NDC 0143-9583

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Irinotecan Hydrochloride (NDC 0143-9583). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa Inc., 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

Chemical Structure (Irinotecan Hydrochloride Injection Usp Novation 1)

Chemical structure of irinotecan hydrochloride, depicting its molecular framework including the distinctive fused ring system and functional groups as represented in the image.*

FDA Label Image

Figure 1. Survival Second-line Irinotecan Vs Best Supportive Care (bsc) Study 7 (Irinotecan Hydrochloride Injection Usp Novation 2)

A Kaplan-Meier survival curve graph comparing the probability of survival over time in months between two groups: Irinotecan and BSC (Best Supportive Care). The graph includes sample sizes (N), median follow-up times, median survival times, and a statistical p-value from a log-rank test.*

FDA Label Image

Figure 2. Survival Second-line Irinotecan Vs Infusion 5-fu Study 8 (Irinotecan Hydrochloride Injection Usp Novation 3)

A Kaplan-Meier survival curve comparing the probability of survival over time (months) between two treatment groups: Irinotecan and 5-FU. The vertical axis shows survival probability from 0 to 1, and the horizontal axis shows months from 0 to 21. The Irinotecan group shows higher survival probability compared to 5-FU, with a p-value of 0.035 indicating statistical significance. Median follow-up and median survival times are noted for each group.*

FDA Label Image

Ndc 0143-9583-01 Rx Only Irinotecan Hydrochloride Injection, Usp 100 mg/5 mL (20 mg/ml) As The Trihydrate For Iv Use Only Must Be Diluted (CYTOTOXIC AGENT 5 mL Single Dose Vial USUAL DOSAGE: See package insert. PROTECT FROM LIGHT. PROTECT FROM FREEZING. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP].)

Label for Irinotecan Hydrochloride Injection, USP 100 mg per 5 mL (20 mg/mL) as the trihydrate, intravenous injection. The label states single dose vial, dilution required with cytotoxic agent, and storage conditions. Distributed by Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ.*

FDA Label Image

Ndc 0143-9583-01 Rx Only Irinotecan Hydrochloride Injection, Usp 100 mg/5 mL (20 mg/ml)* As The Trihydrate For Intravenous Use Only Must Be Diluted Cytotoxic Agent 1 X 5 mL Single Dose Vial (Irinotecan Hydrochloride Injection Usp Novation 5)

Packaging label for Irinotecan Hydrochloride Injection, USP, 100 mg per 5 mL (20 mg/mL) as the trihydrate. The product is an intravenous injection requiring dilution, labeled for single-dose vial use. Manufactured by THYMO MORM GmbH, Germany, and distributed by Hikma Pharmaceuticals USA Inc. Contains warnings about cytotoxic agent and storage instructions.*

FDA Label Image

Irinotecan Hydrochloride Injection Usp Novation 6

The image shows a label for Irinotecan Hydrochloride injection, 20 mg/mL, from Hikma Pharmaceuticals USA Inc. It includes a QR code, GS1 Barcode with GTIN, and printed text for serial number, expiration date, and lot number fields.*

* 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.