Gemcitabine Injection
Product Images NDC 72485-221

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 72485-221). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Armas Pharmaceuticals 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

Carton (Carton1)

This is a label from an outer carton of Gemcitabine Injection, which is a cytotoxic agent. The label includes the drug's name, concentration, dosage, storage instructions, and warnings about potential toxicity. Information on the packaging includes a code for tracking, the manufacturer, and distributor.*

FDA Label Image

Structural Formula (Image01)

FDA Label Image

Figure 1 (Image02)

This is a comparison of median Progression Free Survival between Gemcitabine/Carboplatin and Carboplatin alone. Gemcitabine/Carboplatin had a higher median Progression Free Survival of 8.6 months compared to Carboplatin's 5.8 months. The Log rank p-value was 0.0038, indicating a statistically significant difference between the two treatments. The chart shows the Progression-Free probability for both treatments over time.*

FDA Label Image

Figure 2 (Image03)

This text provides survival data for two treatments in terms of median time to documented disease progression. The first treatment, Gemcitabine/Paclitaxel, had a median time of 5.2 months, while the second treatment, Paclitaxel, had a median time of 2.9 months. The difference between the two treatments was statistically significant with a p-value of <0.0001. The graph shows the progression-free probability over time for both treatments.*

FDA Label Image

Figure 3 (Image04)

This appears to be a table comparing the median survival and one-year survival rates of two treatments (Gemcitabine/Cisplatin and Cisplatin) for an undisclosed medical condition. It also includes a graph showing the survival probability over time and a table displaying test statistics and p-values for the comparison of the two treatments.*

FDA Label Image

Figure 4 (Image05)

This is a graph showing the fraction of individuals who survived after receiving gemcitabine treatment. The x-axis represents the survival time in months and the y-axis shows the fraction of individuals who survived at that point in time. The graph shows data points at 8 and 12 months.*

FDA Label Image

Vial (Vial1)

This is a description of a medication vial with the drug gemcitabine (200mg/5.26mL) and water for injection. It is for intravenous infusion only and must be diluted before use. The vial has been manufactured by Shilpa Medicare Limited and distributed by Armas Pharmaceuticals. The use instructions and cautionary information are available in the package insert. It is a cytotoxic agent, and any unused portion should be discarded. It was packaged on August 2019, and each vial's inner label contains relevant information such as the drug's equivalent and its storage requirements.*

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