Gemcitabine Injection, Powder, Lyophilized, For Solution
Product Images NDC 25021-235

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 25021-235). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sagent Pharmaceuticals, 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

Gem09 0007 01

FDA Label Image

Gem09 0007 02

Median Progression Free Survival is available for two chemotherapy treatments with Gemcitabine/Carboplatin showing a statistically significant improvement (Log rank p=0.0038) over Carboplatin alone. The median progression-free survival for Gemcitabine/Carboplatin is 8.6 months, while Carboplatin has a median progression-free survival of 5.8 months. The x-axis displays progression-free survival in months and the y-axis shows the number of patients who did not experience progression. The figure contains data for 178 individuals receiving Gemcitabine/Carboplatin and 178 persons receiving Carboplatin alone.*

FDA Label Image

Gem09 0007 03

The text describes the median time (in months) for documented disease progression using two drugs: Gemcitabine/Pacitaxel and Paclitaxel. The results show that Gemcitabine/Pacitaxel has a median time of 5.2 months for documented disease progression, while Paclitaxel has a median time of 2.9 months. The difference is statistically significant with a p-value of less than 0.0001. The data is also shown on a graph that displays the number of patients on each drug over time until disease progression is documented.*

FDA Label Image

Gem09 0007 04

This appears to be a comparison of the survival times (in months) for two different treatments, Gemcitabine/Cisplatin and Cisplatin alone, with N262 patients receiving the latter. The survival times for Gem/Cis and Cis are 9.0 months and 7.6 months, respectively. The statistical analysis showing the Logrank value of 0.008 and Wileoxon value of 0.018 are possibly related to the significance of the difference between the two treatments.*

FDA Label Image

Gem09 0007 05

This appears to be a graph with a title "Fraction Surviving" and a horizontal axis labeled "Survival Time (months)" and a vertical axis labeled "Gemitabine". The graph depicts the percentage of patients surviving over time after treatment with Gemitabine. The numbers along the horizontal axis seem to represent the number of months since initial treatment, while the vertical axis appears to represent the percentage of patients still alive at each point. The data itself is not fully legible, but the graph seems to suggest that survival rates decrease over time.*

FDA Label Image

Gem09 0007 06

Gemcitabine for Injection, USP is a medical product that should only be used for Intravenous purposes and it should be handled with caution as it is cytotoxic. Each vial has 200 mg of the gemcitabine solution and is further diluted before use. The NDC number for this product is 25021-234-10. The other text provided seems to be random characters and does not add any valuable information.*

FDA Label Image

Gem09 0007 07

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.