Gemcitabine Injection, Powder, Lyophilized, For Solution
Product Images NDC 71288-113

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 71288-113). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Meitheal 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 (Gem0d 0002 01)

Chemical structure of Gemcitabine Hydrochloride, showing its molecular arrangement with nitrogen, oxygen, fluorine, and hydroxyl groups clearly illustrated in the diagram.*

FDA Label Image

Figure 1 (Gem0d 0002 02)

A Kaplan-Meier survival curve chart comparing progression-free survival between Gemcitabine for Injection/Carboplatin and Carboplatin alone. The x-axis shows progression-free survival in months, and the y-axis shows progression-free probability. The chart includes median progression-free survival times and a log-rank p-value.*

FDA Label Image

Figure 2 (Gem0d 0002 03)

A Kaplan-Meier curve chart titled 'Median Time to Documented Disease Progression' comparing progression-free probability over time in months between two treatment groups: Gemcitabine for Injection/Paclitaxel (N=267) and Paclitaxel alone (N=262). The graph shows longer progression-free time for the combination therapy, with median times of 5.2 months versus 2.9 months, and a reported log-rank p-value less than 0.0001.*

FDA Label Image

Figure 3 (Gem0d 0002 04)

A Kaplan-Meier survival curve comparing two groups: one treated with Gemcitabine and Cisplatin, and the other with Cisplatin alone. The plot displays survival probability on the y-axis and survival time in months on the x-axis, showing median and 1-year survival rates for each group, along with statistical test results and p-values.*

FDA Label Image

Figure 4 (Gem0d 0002 05)

A survival curve graph comparing the fraction surviving over time (months) between Gemcitabine for injection and 5-FU. The x-axis represents survival time in months, and the y-axis shows the fraction surviving, illustrating patient survival rates for the two treatments.*

FDA Label Image

Principal Display Panel (Gemcitabine For Injection, USP 200 mg Vial Label)

Label for Gemcitabine for Injection, USP 200 mg/vial, a lyophilized powder for intravenous injection. The label specifies it as a sterile single-dose vial and a cytotoxic agent. It must be reconstituted and further diluted before use. The label also includes storage instructions and manufacturer information: Meitheal Pharmaceuticals Inc., Chicago, IL.*

FDA Label Image

Principal Display Panel (Gemcitabine For Injection, USP 200 mg Carton)

Pack label for Gemcitabine 200 mg/vial injection powder, lyophilized, for intravenous use. The product is sterile, preservative-free, and labeled as a cytotoxic agent. Manufactured for Meitheal Pharmaceuticals Inc., Chicago, IL. The label includes caution statements, storage instructions, reconstitution directions, and dosage information.*

FDA Label Image

Principal Display Panel – Gemcitabine For Injection, Usp 1 G Vial Label (Gem0d 0002 08)

Label for Gemcitabine injection, USP, 1 g/vial, a sterile single-dose vial of lyophilized powder for intravenous use. The label includes instructions for reconstitution and dilution, indicates the product as a cytotoxic agent, and provides storage and administration details. The labeler is Meitheal Pharmaceuticals Inc.*

FDA Label Image

Principal Display Panel – Gemcitabine For Injection, Usp 1 G Carton (Gem0d 0002 09)

Packaging label for Gemcitabine for Injection, USP, 1 g per vial, a lyophilized powder for intravenous use. The label indicates it is a sterile, single-dose vial requiring reconstitution and further dilution. It is labeled as a cytotoxic agent and manufactured by Meitheal Pharmaceuticals Inc. Storage and reconstitution instructions are also provided on the label.*

* 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.