Irinotecan Hydrochloride Injection
Product Images NDC 0143-9702

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Irinotecan Hydrochloride (NDC 0143-9702). 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 1)

Chemical Structure (Irinotecan Hydrochloride Injection 1)
Chemical structure diagram of Irinotecan Hydrochloride including indications of hydrochloride and trihydrate (3 H2O) components, showing detailed molecular connectivity.*
FDA Label Image

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

Figure 1. Survival Second-line Irinotecan Vs Best Supportive Care (bsc) Study 7 (Irinotecan Hydrochloride Injection 2)
A Kaplan-Meier survival curve chart comparing the probability of survival over months between Irinotecan and BSC (Best Supportive Care) groups. The chart shows higher survival probability for Irinotecan over time with median survival of 9.2 months versus 6.5 months for BSC. Number of subjects and median follow-up time are indicated, along with a 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 3)

Figure 2. Survival Second-line Irinotecan Vs Infusion 5-fu Study 8 (Irinotecan Hydrochloride Injection 3)
A Kaplan-Meier survival probability graph comparing Irinotecan Hydrochloride and 5-FU over 21 months. The y-axis shows probability from 0 to 1, and the x-axis shows months. Curves indicate survival probabilities, with Irinotecan showing higher probability over time than 5-FU. Additional text notes sample sizes, median follow-up, and median months for each treatment.*
FDA Label Image

Ndc 0143-9702-01 Irinotecan Hydrochloride Injection, Usp 40 mg/2 mL (20 mg/ml) As The Trihydrate Must Be Diluted (CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY 2 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 Controlled Room Temperature].)

Ndc 0143-9702-01 Irinotecan Hydrochloride Injection, Usp 40 mg/2 mL (20 mg/ml) As The Trihydrate Must Be Diluted (CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY 2 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 Controlled Room Temperature].)
The label for Irinotecan Hydrochloride Injection USP shows a strength of 40 mg per 2 mL (20 mg/mL) in a 2 mL single-dose vial. The drug is for intravenous use only and must be diluted. The label also includes storage instructions and is manufactured by Hikma Pharmaceuticals USA Inc.*
FDA Label Image

Ndc 0143-9702-01 1 X 2 mL Single Dose Vial Irinotecan Hydrochloride Injection, Usp 40 mg/2 mL (20 mg/ml)* As The Trihydrate Must Be Diluted (CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY)

Ndc 0143-9702-01 1 X 2 mL Single Dose Vial Irinotecan Hydrochloride Injection, Usp 40 mg/2 mL (20 mg/ml)* As The Trihydrate Must Be Diluted (CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY)
Packaging label for Irinotecan Hydrochloride Injection, USP 40 mg per 2 mL (20 mg/mL) injection for intravenous use. The product is labeled as a cytotoxic agent and must be diluted before use. It is supplied as 1 x 2 mL single dose vial, manufactured by THYMOORGAN PHARMAZE GmbH in Germany and distributed by Hikma Pharmaceuticals USA Inc. The label includes storage instructions, warnings, and a barcode.*
FDA Label Image

Ndc 0143-9701-01 Irinotecan Hydrochloride Injection, Usp 100 mg/5 mL (20 mg/ml) As The Trihydrate Must Be Diluted (CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY 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 Controlled Room Temperature].)

Ndc 0143-9701-01 Irinotecan Hydrochloride Injection, Usp 100 mg/5 mL (20 mg/ml) As The Trihydrate Must Be Diluted (CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY 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 Controlled Room Temperature].)
Label for Irinotecan Hydrochloride Injection, USP, 100 mg per 5 mL (20 mg/mL) sterile single-dose vial. The label indicates the drug is for intravenous use only and must be diluted prior to use. It is labeled by Hikma Pharmaceuticals USA Inc. and includes storage instructions and lot/expiration information.*
FDA Label Image

Ndc 0143-9701-01 1 X 5 mL Single Dose Vial Irinotecan Hydrochloride Injection, Usp 100 mg/5 mL (20 mg/ml)* As The Trihydrate Must Be Diluted (CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY)

Ndc 0143-9701-01 1 X 5 mL Single Dose Vial Irinotecan Hydrochloride Injection, Usp 100 mg/5 mL (20 mg/ml)* As The Trihydrate Must Be Diluted (CYTOTOXIC AGENT FOR IV USE ONLY Rx ONLY)
Packaging label for Irinotecan Hydrochloride Injection, USP, 100 mg per 5 mL (20 mg/mL) as the trihydrate. Injection is for intravenous use only, supplied as a single-dose 5 mL vial. Manufactured by THYMOORGAN PHARMAZIE GmbH, distributed by Hikma Pharmaceuticals USA Inc. The label includes dilution instructions, storage conditions, and cytotoxic agent warnings.*
FDA Label Image

Irinotecan Hydrochloride Injection 8

Irinotecan Hydrochloride Injection 8
This image shows a label featuring a QR code and printed alphanumeric information including GTIN, serial number (SN), expiration date (EXP), and lot number (LOT). The label contains no brand or product name but is consistent with packaging components used for Irinotecan Hydrochloride 20 mg/mL injection by Hikma Pharmaceuticals USA Inc.*

* 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.