Gemcitabine Injection, Solution
Product Images NDC 67457-618

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 67457-618). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Institutional Llc, 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

Structure (Image 01)

Chemical structure of gemcitabine hydrochloride, showing the pyrimidine ring with amine and keto groups, a sugar moiety with hydroxyl groups, and two fluorine atoms attached to the sugar ring.*

FDA Label Image

Figure 1 (Image 02)

A Kaplan-Meier curve chart depicting progression-free survival probabilities over months for two treatment groups: Gemcitabine/Carboplatin and Carboplatin alone. The vertical axis shows progression-free probability, and the horizontal axis shows progression-free survival in months. A median progression-free survival table compares 8.6 months for Gemcitabine/Carboplatin versus 5.8 months for Carboplatin, with a log-rank p-value of 0.0038.*

FDA Label Image

Figure 2 (Image 03)

Kaplan-Meier curves illustrating time to documented disease progression in Study 2 comparing Gemcitabine plus Paclitaxel versus Paclitaxel alone. The graph plots progression-free probability over time in months, showing longer median progression-free time with Gemcitabine/Paclitaxel (5.2 months) compared to Paclitaxel (2.9 months).*

FDA Label Image

Figure 3 (Image 04)

A Kaplan-Meier survival curve graph showing overall survival in Study 3. The vertical axis represents survival probability (0 to 1.0), and the horizontal axis shows survival time in months (0 to 25 months). Two survival curves compare Cisplatin (N=262) and Gemcitabine/Cisplatin (N=260) treatment groups with median survival and 1-year survival percentages listed, along with p-values for Logrank and Wilcoxon tests.*

FDA Label Image

Figure 4 (Image 05)

A Kaplan-Meier survival curve graph titled 'Kaplan-Meier Curves for Overall Survival in Study 5' comparing overall survival between Gemcitabine and 5-FU treatments. The x-axis represents survival time in months (0 to 20), and the y-axis shows the fraction surviving (0 to 1). Two curves are labeled: Gemcitabine (upper curve) and 5-FU (lower curve), depicting survival probability over time.*

FDA Label Image

Carton 200 mg (Image 06)

Label for Gemcitabine Injection 200 mg/5.26 mL (38 mg/mL) single-dose vial by Mylan Institutional LLC. The packaging includes NDC 67457-616-10, instructions for intravenous infusion, and caution that gemcitabine is a cytotoxic agent. It notes the product is sterile, must be diluted before use, and includes storage instructions. The label also shows the manufacturer address and a barcode.*

FDA Label Image

Carton 1 G (Image 07)

Label for Gemcitabine Injection 1 g/26.3 mL (38 mg/mL) solution for intravenous infusion by Mylan Institutional LLC. The label includes storage instructions, cytotoxic agent caution, dilution requirement, and single-dose vial indication. Manufactured in India with NDC 67457-617-30.*

FDA Label Image

Carton 2 G (Image 08)

Label for Gemcitabine Injection 2 g/52.6 mL (38 mg/mL) intravenous solution by Mylan Institutional LLC. The carton indicates it is a single-dose vial, cautions that Gemcitabine is a cytotoxic agent, and instructs dilution before use. Storage instructions specify 2° to 8°C and to avoid freezing. The label includes barcodes and manufacturing details.*

* 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.