Gemcitabine Injection, Powder, Lyophilized, For Solution
Product Images NDC 0409-0185

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Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 0409-0185). 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 components including fluorine atoms and nitrogenous base. The diagram depicts the arrangement of atoms in the molecule as related to its lyophilized injection form by Hospira, Inc.*
FDA Label Image

Figure 1: Kaplan-meier Curve Of Progression Free Survival In Gemcitabine Plus Carboplatin Versus Carboplatin In Ovarian Cancer (n=356) (Gemcitabine 02)

Figure 1: Kaplan-meier Curve Of Progression Free Survival In Gemcitabine Plus Carboplatin Versus Carboplatin In Ovarian Cancer (n=356) (Gemcitabine 02)
A Kaplan-Meier survival curve comparing progression-free survival probabilities over time (months) between Gemcitabine/Carboplatin and Carboplatin alone in 178 patients each. The graph shows median progression-free survival times of 8.6 months for Gemcitabine/Carboplatin and 5.8 months for Carboplatin, with a log-rank p-value of 0.0038.*
FDA Label Image

Figure 2 (Gemcitabine 03)

Figure 2 (Gemcitabine 03)
A Kaplan-Meier curve graph showing progression-free probability over time in months for two groups: Gemcitabine/Paclitaxel (N=267) and Paclitaxel alone (N=262). The graph compares median time to documented disease progression of 5.2 months versus 2.9 months, respectively, with a log-rank p-value less than 0.0001.*
FDA Label Image

Figure 3 (Gemcitabine 04)

Figure 3 (Gemcitabine 04)
A Kaplan-Meier survival curve graph showing survival probability over time in months for patients treated with Gemcitabine/Cisplatin versus Cisplatin alone. The graph includes median survival times (9.0 months for Gemcitabine/Cisplatin, 7.6 months for Cisplatin) and 1-year survival percentages (39% and 28%, respectively). Test statistics and p-values for Logrank and Wilcoxon tests are provided.*
FDA Label Image

Figure 4 (Gemcitabine 05)

Figure 4 (Gemcitabine 05)
A survival curve chart comparing Gemcitabine and 5-FU, showing fraction surviving versus survival time in months. The chart illustrates survival probabilities over time for patients treated with Gemcitabine and 5-FU.*
FDA Label Image

Hospira Logo (Gemcitabine 06)

FDA Label Image

Principal Display Panel (200 mg Vial Label)

Principal Display Panel (200 mg Vial Label)
Label for Gemcitabine for Injection, USP 200 mg/Vial lyophilized powder for intravenous use, single-dose vial. It includes preparation instructions, storage conditions at 20° to 25°C, and a caution that it is a cytotoxic agent. The label also displays the NDC 0409-0185-01 and is distributed by Hospira, Inc.*
FDA Label Image

Principal Display Panel (200 mg Vial Carton)

Principal Display Panel (200 mg Vial Carton)
Packaging label for Gemcitabine for Injection, USP 200 mg/Vial (lyophilized) powder for solution. The label shows a single-dose vial for intravenous use only, distributed by Hospira, Inc. It includes cautionary statements indicating the product is a cytotoxic agent. Storage and reconstitution instructions are provided on the label.*
FDA Label Image

Principal Display Panel (1 g Vial Label)

Principal Display Panel (1 g Vial Label)
Label for Gemcitabine for Injection, USP, 1 g per vial, lyophilized powder for solution. It specifies the drug is a single-dose vial intended for intravenous use. The label includes cautionary text regarding cytotoxicity and provides manufacturer details for Hospira, Inc. It also displays storage instructions, dosage preparation directions, and a barcode.*
FDA Label Image

Principal Display Panel (1 g Vial Carton)

Principal Display Panel (1 g Vial Carton)
Packaging label for Gemcitabine for Injection, USP 1 g/vial lyophilized powder for solution, labeled for intravenous use only. The label includes cautions for cytotoxic agents, reconstitution instructions to 38 mg/mL for infusion, storage conditions, and distribution details by Hospira, Inc. The label design features a blue vial icon and a red caution bar.*

* 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.