Gemcitabine
Product Images NDC 72485-223

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 72485-223). 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)

Chemical structure of Gemcitabine hydrochloride, showing its molecular arrangement with hydroxyl, fluorine, amino groups, and a pyrimidine ring.*

FDA Label Image

Figure 1 (Image02)

A Kaplan-Meier curve displaying progression-free survival probability over months for Gemcitabine/Carboplatin versus Carboplatin alone in 178 patients each. The graph compares progression-free probability on the y-axis against progression-free survival time in months on the x-axis. Median progression-free survival times are noted as 8.6 months for Gemcitabine/Carboplatin and 5.8 months for Carboplatin, with a log-rank p-value of 0.0038.*

FDA Label Image

Figure 2 (Image03)

A Kaplan-Meier curve chart depicting progression-free probability over time in months to documented disease progression. It compares two treatments: Gemcitabine/Paclitaxel and Paclitaxel alone, showing median times to disease progression of 5.2 months and 2.9 months respectively, with sample sizes of 178 and 262.*

FDA Label Image

Figure 3 (Image04)

A survival probability curve comparing Gemcitabine/Cisplatin and Cisplatin alone over time in months. Median survival and 1-year survival percentages are noted for each group, along with statistical test results including Logrank and Wilcoxon p-values.*

FDA Label Image

Figure 4 (Image05)

A survival curve chart comparing the fraction surviving over time (months) between two treatments: Gemcitabine and 5-FU. The x-axis represents survival time in months, and the y-axis represents the fraction surviving, ranging from 0 to 1. The chart shows two lines representing survival rates for patients treated with Gemcitabine and 5-FU respectively.*

FDA Label Image

Vial (Image8)

Inner vial label for Gemcitabine Injection 2 g/52.6 mL (38 mg/mL), manufactured by Shilpa Medicare Limited and distributed by Armas Pharmaceuticals Inc. The label states it is for intravenous infusion only, must be diluted before use, and contains 1 single dose vial. It includes storage instructions and a caution for cytotoxic agent.*

FDA Label Image

Carton (Image9)

Outer carton label for Gemcitabine Injection 2 g/52.6 mL (38 mg/mL) by Armas Pharmaceuticals Inc. The label indicates single-dose vial, intravenous infusion only, and storage at 2 to 8°C. It includes a cytotoxic agent caution and states the product is manufactured by Shilpa Medicare Limited, India, and distributed by Armas Pharmaceuticals in New Jersey, USA.*

* 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.