Gemcitabine Injection, Solution
Product Images NDC 0143-9342

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 0143-9342). 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)

FDA Label Image

Figure 1 (Gemcitabine Injection 2)

Figure 1 (Gemcitabine Injection 2)
Not available.*
FDA Label Image

Figure 2 (Gemcitabine Injection 3)

Figure 2 (Gemcitabine Injection 3)
This text provides data on the progression-free probability of patients receiving Gemcitabine/Paclitaxel compared to Paclitaxel alone. The median time to documented disease progression was 5.2 months for Gemcitabine/Paclitaxel and 2.9 months for Paclitaxel alone. The statistical analysis showed a significant difference between the two groups with a p-value of less than 0.0001. The chart displays the progression-free probability over time for both treatment groups.*
FDA Label Image

Figure 3 (Gemcitabine Injection 4)

Figure 3 (Gemcitabine Injection 4)
This text provides survival data for patients who received Gemcitabine/Cisplatin and Cisplatin treatment. The median survival for Gem/Cis was 9.0 months with a 1-year survival rate of 39%, while for Cisplatin, the median survival was 7.6 months with a 1-year survival rate of 28%. Test statistics such as Logrank (p=0.008) and Wilcoxon (p=0.018) are provided for comparison. The study included 260 patients in the Gemcitabine/Cisplatin group and 262 patients in the Cisplatin group for evaluating survival time in months.*
FDA Label Image

Image Of Figure 4 (Gemcitabine Injection 5)

Image Of Figure 4 (Gemcitabine Injection 5)
This text provides data on the fraction surviving at different time points, as well as survival times for 5-FU and Gemcitabine treatments in months. The information can be used to analyze and compare the efficacy of these treatments in terms of patient survival rates.*
FDA Label Image

Gemcitabine 200mg Vial (Gemcitabine Injection 6)

Gemcitabine 200mg Vial (Gemcitabine Injection 6)
This is a product label providing information about a medication containing 200 mg of gemcitabine. The medication is in an injection form and comes in a single-dose vial of 5.26 mL. The label also indicates to discard any unused portions of the medication. This product is for prescription use only.*
FDA Label Image

Gemcitabine 1g Vial (Gemcitabine Injection 7)

Gemcitabine 1g Vial (Gemcitabine Injection 7)
This is a product label for gemcitabine injection, a cytotoxic agent used for intravenous infusion only. Each single-dose vial contains 1g of gemcitabine to be diluted before use. The storage instructions suggest keeping it at 2°C to 8°C. The product is manufactured by Thymoorgan Pharmazie GmbH in Germany and distributed by Hikma in Berkeley Heights, New Jersey.*
FDA Label Image

Gemcitabine 2g Vial (Gemcitabine Injection 8)

Gemcitabine 2g Vial (Gemcitabine Injection 8)
This is a description of a vial of gemcitabine, a cytotoxic agent used for injection. The vial contains 2.227 grams of gemcitabine and must be diluted before intravenous infusion. It should be stored at 2° to 8°C. The product is manufactured by THYMOORGAN PHARMAZIE in Germany and distributed by a company located in Berkeley Heights, NJ. Unused potion should be discarded. Dosing and administration instructions can be found in the package insert.*

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