Gemcitabine Injection, Powder, Lyophilized, For Solution
Product Images NDC 0409-0187

8 FDA label images from Hospira, Inc. · 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 Gemcitabine (NDC 0409-0187). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hospira, 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

Structural Formula Gemcitabine (Gemcitabine 01)

Structural Formula Gemcitabine (Gemcitabine 01)
Chemical structure of gemcitabine showing its molecular framework with two fluorine atoms attached to the sugar ring and an amino group as part of the pyrimidine base.*
FDA Label Image

Figure 1: Kaplan-meier Curve Of Progression Free Survival In Gemcitabine Plus Carboplatin Versus Carboplatin In Ovarian Cancer (Gemcitabine 02)

Figure 1: Kaplan-meier Curve Of Progression Free Survival In Gemcitabine Plus Carboplatin Versus Carboplatin In Ovarian Cancer (Gemcitabine 02)
A Kaplan-Meier survival curve graph showing progression-free survival probability over time (months) for two groups: Gemcitabine/Carboplatin and Carboplatin alone. The graph compares progression-free survival rates, indicating a median progression-free survival of 8.6 months for Gemcitabine/Carboplatin versus 5.6 months for Carboplatin with a noted statistical significance (p=0.0038).*
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Figure 2: Kaplan-meier Curve Of Time To Documented Disease Progression In Gemcitabine Plus Paclitaxel Versus Paclitaxel Breast Cancer Study (Gemcitabine 03)

Figure 2: Kaplan-meier Curve Of Time To Documented Disease Progression In Gemcitabine Plus Paclitaxel Versus Paclitaxel Breast Cancer Study (Gemcitabine 03)
A Kaplan-Meier survival curve graph showing progression-free probability over time in months. Two comparison groups are plotted: Gemcitabine/Paclitaxel (N=267) and Paclitaxel alone (N=262). The graph illustrates median time to documented disease progression as 5.2 months for Gemcitabine/Paclitaxel and 2.9 months for Paclitaxel, with a log rank p-value less than 0.0001.*
FDA Label Image

Xen-1822-4figure 3: Kaplan-meier Survival Curve In Gemcitabine Plus Cisplatin Versus Cisplatin Nsclc Study (Gemcitabine 04)

Xen-1822-4figure 3: Kaplan-meier Survival Curve In Gemcitabine Plus Cisplatin Versus Cisplatin Nsclc Study (Gemcitabine 04)
A Kaplan-Meier survival curve comparing survival probability over time (months) for Cisplatin alone and Gemcitabine/Cisplatin treatment groups. The graph shows median survival times and 1-year survival percentages, with statistical test results including logrank and Wilcoxon p-values indicating significance.*
FDA Label Image

Figure 4: Kaplan-meier Survival Curve (Gemcitabine 05)

Figure 4: Kaplan-meier Survival Curve (Gemcitabine 05)
A survival curve chart comparing fraction surviving over time in months for Gemcitabine and 5-FU. The x-axis represents survival time up to 20 months, and the y-axis shows the fraction surviving from 0 to 1. The chart shows separate stepwise lines for Gemcitabine and 5-FU survival outcomes.*
FDA Label Image

Hospira Logo (Gemcitabine 06)

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Principal Display Panel (2 g Vial Label)

Principal Display Panel (2 g Vial Label)
Label for Gemcitabine for Injection, USP, 2 g/vial lyophilized powder for intravenous use. The label includes warnings such as 'Caution: Cytotoxic Agent,' storage instructions at 20 to 25°C, and handling directions. Manufactured by Hospira, Inc. in Lake Forest, IL. The NDC number 0409-0187 is shown.*
FDA Label Image

Principal Display Panel (2 g Vial Carton)

Principal Display Panel (2 g Vial Carton)
Packaging label for Gemcitabine for Injection, USP 2 g/vial (lyophilized powder) by Hospira, Inc. The label indicates it is a sterile, single-dose vial for intravenous use only. The vial is supplied as a 1 x 2 g vial, with a caution indicating it is a cytotoxic agent and instructions not to refrigerate. The label includes storage and reconstitution information and warnings.*

* 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.