Gemcitabine Injection
Product Images NDC 72485-222

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Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 72485-222). 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

Structural Formula (Image01)

FDA Label Image

Figure 1 (Image02)

Figure 1 (Image02)
The text describes the median progression-free survival rates for Gemcitabine/Carboplatin and Carboplatin alone. The median progression-free survival rate for Gemcitabine/Carboplatin was 8.6 months while it was 5.8 months for Carboplatin alone. The study involved 178 participants and the log-rank p-value was 0.0038. The text also shows a graph of progression-free survival rates for both treatments up to 42 months.*
FDA Label Image

Figure 2 (Image03)

Figure 2 (Image03)
This is a statistical report comparing Gemcitabine/Paclitaxel to Paclitaxel in the treatment of a disease. The report shows the median time to documented disease progression for each treatment, with Gemcitabine/Paclitaxel having a longer time of 5.2 months and Paclitaxel of 2.9 months. The report also includes a graph plotting the time to documented disease progression against the probability of progression-free at each point in time for each treatment. The data shows a significant difference between the two treatments with a Logrank p<0.0001.*
FDA Label Image

Figure 3 (Image04)

Figure 3 (Image04)
This is a description of a comparison study between Gemcitabine/Cisplatin and Cisplatin treatments for a medical condition with a sample size of 260 and 262 respectively. The comparison is based on two statistical values - log rank and Wilcoxon - with p-values of 0.008 and 0.018 respectively. The study also includes a graph showing the survival probability of both treatments with the median survival of 9.0 and 7.6 months for Gemcitabine/Cisplatin and Cisplatin respectively.*
FDA Label Image

Figure 4 (Image05)

Figure 4 (Image05)
This appears to be a graph or chart that displays survival rates for patients treated with a drug called Gemcitabine over a period of 8-12 months. The term "Fraction Surviving" likely refers to the percentage of patients who continue to survive during the treatment period. More information about the study, such as the patient population and specific survival rates, cannot be determined from the given text.*
FDA Label Image

Label1 (Image06)

Label1 (Image06)
This is a description for a vial of PR injection containing 1g gemcitabine hydrochloride equivalent to 1139g gemcitabine. It is intended for infusion only and must be stored at a specific temperature. The package insert provides instructions for dosing and administration, and any unused portion should be discarded. It also includes a caution that it is a cytotoxic agent. The label is from Ronly, with the NDC number 72485-222-10 and was distributed by Vel Armas, in August 2019.*
FDA Label Image

Label2 (Image7)

Label2 (Image7)
This text is a description of a Gemcitabine injection, a cytotoxic agent, used for intravenous infusion. The drug comes in a 26.3 mL single-dose vial and must be diluted before use. It should be stored in a temperature range of 2-8°C (36 to 46°F) and any unused portion should be discarded. The vial contains 1 g gemcitabine, equivalent to 1.139 g gemcitabine hydrochloride, with water for injection, USP. The pH may have been adjusted with hydrochloric acid, NF and/or sodium hydroxide, NF. The outer carton label also displays a product code and the manufacturers and distributors.*

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