Gemcitabine Injection, Powder, Lyophilized, For Solution
Product Images NDC 63323-126

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 63323-126). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, Llc, 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 (Gem0k 0001 01)

Chemical structure of gemcitabine hydrochloride, showing a nucleoside analog with a fluorine substitution on the sugar ring and an attached hydrochloride group on the nitrogen base.*

FDA Label Image

Figure 1 (Gem0k 0001 02)

A Kaplan-Meier curve chart showing progression-free survival probabilities over time in months for two treatment groups: Gemcitabine/Carboplatin and Carboplatin alone. The graph compares median progression-free survival durations and a p-value indicating statistical significance between the treatments.*

FDA Label Image

Figure 2 (Gem0k 0001 03)

A Kaplan-Meier curve chart comparing progression-free probability over time (in months) between two treatment groups: Gemcitabine/Paclitaxel and Paclitaxel alone. The chart indicates median time to documented disease progression of 5.2 months for Gemcitabine/Paclitaxel and 2.9 months for Paclitaxel, with sample sizes of N=267 and N=262 respectively.*

FDA Label Image

Figure 3 (Gem0k 0001 04)

A Kaplan-Meier survival curve chart comparing survival probability over time (months) for patients treated with Gemcitabine/Cisplatin versus Cisplatin alone. The chart shows median survival times and 1-year survival percentages, along with statistical test results (Logrank and Wilcoxon) evaluating differences between the groups.*

FDA Label Image

Figure 4 (Gem0k 0001 05)

A survival curve graph comparing fraction surviving over time for Gemcitabine versus 5-FU. The x-axis represents survival time in months, ranging from 0 to 20, and the y-axis represents fraction surviving from 0 to 1. The Gemcitabine curve indicates longer survival compared to the 5-FU curve.*

FDA Label Image

Fresenius Kabi Logo (Gem0k 0001 06)

FDA Label Image

Vial (Gem0k 0001 07)

Label for GEMCITABINE for Injection, USP 2 g single dose vial by Fresenius Kabi USA, LLC. The label includes instructions for IV use, dilution requirement, storage conditions at 20° to 25°C, and a caution that the vial closure is not made with natural rubber latex. The label also features the NDC 63323-126-00 and a barcode.*

FDA Label Image

Carton (Gem0k 0001 08)

Packaging label for GEMCITABINE 2 g/50 mL for injection, USP by Fresenius Kabi USA, LLC. The label includes drug storage and preparation instructions, a warning that the product is cytotoxic and for IV use only, the requirement for dilution, and that it is a single-dose vial. The NDC is 63323-126-00.*

* 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.