Gemcitabine Injection, Solution
Product Images NDC 0409-0183

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 0409-0183). 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

Chemical Structure (Gemcitabine 01)

Chemical Structure (Gemcitabine 01)
Chemical structure of gemcitabine hydrochloride, showing the molecular arrangement of atoms including fluorine, nitrogen, oxygen, and hydrogen components typical of this active ingredient.*
FDA Label Image

Figure 1 (Gemcitabine 02)

Figure 1 (Gemcitabine 02)
A Kaplan-Meier survival curve graph showing median progression-free survival with Gemcitabine/Carboplatin versus Carboplatin alone. The x-axis represents progression-free survival in months, and the y-axis represents progression-free probability. The graph compares two groups (N=178 each) with median survival of 8.6 months for Gemcitabine/Carboplatin and 5.8 months for Carboplatin. A log rank test p-value of 0.0038 is noted.*
FDA Label Image

Figure 2 (Gemcitabine 03)

Figure 2 (Gemcitabine 03)
A Kaplan-Meier curve chart showing progression-free probability over time in months for two treatment groups: Gemcitabine/ Paclitaxel and Paclitaxel alone. The graph includes median time to documented disease progression for Gemcitabine/Paclitaxel at 5.2 months, and Paclitaxel at 2.9 months, 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 comparing survival probabilities over time in months for patients treated with Gemcitabine/Cisplatin versus Cisplatin alone. The graph shows median survival times of 9.0 months for Gemcitabine/Cisplatin and 7.6 months for Cisplatin, with 1-year survival rates of 39% and 28% respectively. Statistical test results (Logrank and Wilcoxon) and p-values are included to indicate significance.*
FDA Label Image

Figure 4 (Gemcitabine 05)

Figure 4 (Gemcitabine 05)
A survival curve chart comparing the fraction surviving over time (in months) between Gemcitabine and 5-FU treatments. The vertical axis represents the fraction surviving, ranging from 0 to 1, and the horizontal axis represents survival time up to 20 months. The Gemcitabine curve shows higher survival fractions over time compared to the 5-FU curve.*
FDA Label Image

Logo (Gemcitabine 06)

FDA Label Image

Principal Display Panel (1 g/26.3 mL Vial Label)

Principal Display Panel (1 g/26.3 mL Vial Label)
Gemcitabine Injection 1 g/26.3 mL (38 mg/mL) solution vial label. It indicates intravenous use and cautions the solution must be diluted before use. Storage recommended at 2 to 8°C. The label includes a red warning that the product is cytotoxic and provides manufacturer information for Hospira, Inc.*
FDA Label Image

Principal Display Panel (1 g/26.3 mL Vial Carton)

Principal Display Panel (1 g/26.3 mL Vial Carton)
Packaging label for Gemcitabine Injection, 1 g/26.3 mL (38 mg/mL) solution for intravenous use. Distributed by Hospira, Inc. The label includes dilution instructions, storage conditions (2 to 8°C), and warnings about cytotoxicity, highlighting precautions to avoid inhalation and skin exposure. It is a single-dose vial with unused portions to be discarded.*
FDA Label Image

Principal Display Panel (200 mg/5.26 mL Vial Label)

Principal Display Panel (200 mg/5.26 mL Vial Label)
Label for Gemcitabine Injection 200 mg/5.26 mL (38 mg/mL) intravenous injection solution. The label includes storage instructions, dosage form, and caution about cytotoxicity. It specifies the vial volume, single-dose use, and distributor Hospira, Inc., Lake Forest, IL, USA. Barcode and NDC number 0409-0183-01 are visible.*
FDA Label Image

Principal Display Panel (200 mg/5.26 mL Vial Carton)

Principal Display Panel (200 mg/5.26 mL Vial Carton)
Packaging label for Gemcitabine Injection 200 mg/5.26 mL (38 mg/mL), an intravenous injection solution. The carton includes dosage strength, volume, usage instructions indicating it must be diluted before use, storage conditions (2 to 8°C), and manufacturer Hospira, Inc. The label also cautions that the drug is a cytotoxic agent and should be handled with care.*
FDA Label Image

Principal Display Panel (2 g/52.6 mL Vial Label)

Principal Display Panel (2 g/52.6 mL Vial Label)
Label for Gemcitabine Injection 2 g/52.6 mL (38 mg/mL) intravenous injection solution, manufactured by Hospira, Inc. It is a 52.6 mL single-dose vial requiring dilution before use, stored at 2 to 8 degrees Celsius. The label contains cautionary information indicating it is a cytotoxic agent and includes storage and disposal instructions.*
FDA Label Image

Principal Display Panel (2 g/52.6 mL Vial Carton)

Principal Display Panel (2 g/52.6 mL Vial Carton)
Gemcitabine Injection 2 g/52.6 mL (38 mg/mL) solution for intravenous use, single-dose vial. The label includes dosing instructions, storage at 2 to 8°C, and cautions that the product is cytotoxic and must be diluted before use. Distributed by Hospira, Inc., Lake Forest, IL.*

* 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.