Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution
Product Images NDC 68083-148

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Gemcitabine Hydrochloride (NDC 68083-148). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Gland Pharma Limited, 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

Gemcitabine-carton-label-1-g (Gemcitabine Carton Label 1 G)

Packaging label for Gemcitabine for Injection, USP 1 gram per vial, lyophilized powder for solution. The label states the drug must be reconstituted and further diluted for intravenous use only and cautions that it is a cytotoxic agent. It includes storage instructions, manufacturer details for Gland Pharma Limited in India, and a barcode. The label emphasizes the product is a single-dose vial and not to refrigerate.*

FDA Label Image

Gemcitabine-carton-label-200-mg (Gemcitabine Carton Label 200 mg)

Packaging label for Gemcitabine for Injection, USP, 200 mg per vial, a sterile lyophilized powder for intravenous injection. The label states it must be reconstituted and further diluted, with caution for cytotoxic agent handling. Manufactured by Gland Pharma Limited, with storage instructions and barcode on the label.*

FDA Label Image

Gemcitabine-vial-label-1-g (Gemcitabine Vial Label 1 G)

Label for Gemcitabine for Injection, USP, 1 gram per vial, lyophilized powder for intravenous injection. The label states the product must be reconstituted and further diluted, is for intravenous use only, and must not be refrigerated. It includes a caution for cytotoxic agent. Manufactured by Gland Pharma Limited, India, with instructions for reconstitution and storage at controlled room temperature.*

FDA Label Image

Gemcitabine-vial-label-200-mg (Gemcitabine Vial Label 200 mg)

Label for Gemcitabine for Injection, USP 200 mg per vial, lyophilized powder for intravenous use. The label states it must be reconstituted and further diluted, is for single-dose vial, and cautions it is a cytotoxic agent. Manufactured by Gland Pharma Limited, India, with storage instructions and barcode present.*

FDA Label Image

Fig1 (Image1)

Chemical structure of gemcitabine hydrochloride showing its molecular components with labeled functional groups, including fluorine atoms and nitrogen-containing rings.*

FDA Label Image

Fig2 (Image2)

A Kaplan-Meier survival curve chart showing Progression-Free Survival probability over time in months. The graph compares Gemcitabine/Carboplatin combination therapy (N=178) to Carboplatin alone (N=178), indicating higher progression-free survival for the combination. Median progression-free survival durations are 8.6 months for Gemcitabine/Carboplatin and 5.8 months for Carboplatin, with a log rank p-value of 0.0038.*

FDA Label Image

Fig3 (Image3)

A Kaplan-Meier curve chart showing progression-free probability over time to documented disease progression in months. The graph compares two groups: Gemcitabine/Paclitaxel (N=267) and Paclitaxel alone (N=262). The median times to disease progression are 5.2 months for Gemcitabine/Paclitaxel and 2.9 months for Paclitaxel, with a log-rank p-value less than 0.0001.*

FDA Label Image

Fig4 (Image4)

A survival probability Kaplan-Meier curve comparing Gemcitabine/Cisplatin (N=260) and Cisplatin (N=262) treatments over 25 months. The graph shows survival probability on the vertical axis and survival time in months on the horizontal axis, indicating higher survival for Gemcitabine/Cisplatin with median survival of 9 months versus 7.6 months for Cisplatin. One-year survival rates are 39% for Gemcitabine/Cisplatin and 28% for Cisplatin, with associated logrank and Wilcoxon p-values of 0.008 and 0.018, respectively.*

FDA Label Image

Image5 (Image5)

A survival time chart comparing gemcitabine and 5-FU treatments, showing the fraction of patients surviving over a period of up to 20 months. The graph illustrates longer survival times associated with gemcitabine compared to 5-FU.*

* 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.