Gemcitabine Injection, Solution
Product Images NDC 0143-9341

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 0143-9341). 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

Structural Formula (Gemcitabine Injection 1)

Chemical structure of gemcitabine hydrochloride illustrating its molecular components including the pyrimidine base and sugar moiety with fluorine atoms.*

FDA Label Image

Figure 1 (Gemcitabine Injection 2)

A Kaplan-Meier plot illustrating median progression-free survival for Gemcitabine/Carboplatin versus Carboplatin alone. The x-axis shows progression-free survival in months, and the y-axis shows progression-free probability. The graph compares survival curves and notes median progression-free survival times and statistical significance.*

FDA Label Image

Figure 2 (Gemcitabine Injection 3)

A Kaplan-Meier curve graph depicting progression-free probability over time in months for two treatment groups: Gemcitabine/Paclitaxel (N=267) and Paclitaxel alone (N=262). The graph shows median time to documented disease progression of 5.2 months for Gemcitabine/Paclitaxel compared to 2.9 months for Paclitaxel, with a log rank p-value less than 0.0001, indicating statistical difference.*

FDA Label Image

Figure 3 (Gemcitabine Injection 4)

A Kaplan-Meier survival curve comparing survival probability over time (months) between two groups: Cisplatin (N=262) and Gemcitabine/Cisplatin (N=260). The graph shows median survival of 7.6 months for Cisplatin and 9.0 months for the combination, with 1-year survival rates of 28% and 39%, respectively. Statistical test p-values for Logrank (0.008) and Wilcoxon (0.018) are included.*

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Image Of Figure 4 (Gemcitabine Injection 5)

A survival curve chart comparing Gemcitabine and 5-FU showing the fraction of patients surviving over time in months. The vertical axis represents the fraction surviving from 0.0 to 1.0, and the horizontal axis represents survival time up to 20 months. The Gemcitabine curve is consistently above the 5-FU curve, indicating longer survival times.*

FDA Label Image

Gemcitabine 200mg Vial (Gemcitabine Injection 6)

Label for Gemcitabine Injection 200 mg per 5.26 mL (38 mg/mL) single-dose vial by Hikma Pharmaceuticals USA Inc. Contains 200 mg gemcitabine per vial for intravenous infusion. Instructions include dilution before use, storage between 2°C to 8°C, and disposal of unused portion. Manufactured by THYMOORGAN PHARMAZIE GmbH in Germany and distributed by Hikma in New Jersey.*

FDA Label Image

Gemcitabine 1g Vial (Gemcitabine Injection 7)

Label for Gemcitabine Injection 1 g per 26.3 mL (38 mg/mL) intravenous solution. The label instructs that it is for intravenous infusion only and must be diluted before use. It notes Gemcitabine as a cytotoxic agent and provides storage instructions and manufacturing details by THYMOORGAN PHARMAZIE GmbH, Germany, with distribution in Berkeley Heights, NJ.*

FDA Label Image

Gemcitabine 2g Vial (Gemcitabine Injection 8)

Label for Gemcitabine Injection 2 g per 52.6 mL (38 mg/mL) intravenous solution, single-dose vial, by Hikma Pharmaceuticals USA Inc. The label includes dilution and storage instructions, manufacturer and distributor details, a warning for cytotoxicity, and dosage information. The product is for intravenous infusion only and must be diluted before use.*

* 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.