Gemcitabine
Product Images NDC 55390-391

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 55390-391). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bedford Laboratories, 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

1carton (1carton)

Gemcitabine 1 g sterile single-use vial label for injection by Bedford Laboratories. The label specifies intravenous use only, lyophilized powder requiring dilution, and storage at controlled room temperature. It includes preparation, dosage, and safety information, along with manufacturer and distributor details.*

FDA Label Image

1vial (1vial)

Label for Gemcitabine for Injection, USP, 1 gram vial, a cytotoxic agent labeled for single use only, manufactured by Dr. Reddy's Laboratories Limited and distributed by Bedford Laboratories. The label includes dosage reconstitution instructions, storage conditions, and the NDC number 55390-391-50.*

FDA Label Image

200carton (200carton)

Packaging label for gemcitabine 200 mg for injection, USP by Bedford Laboratories. The label indicates a sterile single-use vial, lyophilized cytotoxic agent for intravenous use only. Instructions include dilution requirements and storage conditions. The label also notes manufacturing by Dr. Reddy's Laboratories Ltd. in India and distribution by Bedford Laboratories in Ohio.*

FDA Label Image

200vial (200vial)

Label for gemcitabine injection, USP, 200 mg strength. The label indicates the product is for intravenous use only and is a cytotoxic agent, Rx only. It is a sterile single-use vial, lyophilized and must be diluted. The label includes reconstitution instructions, storage conditions, and manufacturer information listing Dr. Reddy's Laboratories Ltd., India. The product is distributed by Bedford Laboratories with NDC 55390-391.*

FDA Label Image

Figure1 (Figure1)

A Kaplan-Meier curve comparing progression-free survival over months for Gemcitabine For Injection/Carboplatin versus Carboplatin alone. The y-axis shows progression-free probability, and the x-axis shows progression-free survival in months up to 42 months. The plot indicates a higher progression-free probability over time for the combination therapy (N=178) compared to Carboplatin alone (N=178). A table inset provides median progression-free survival times with 8.6 months for the combination and 5.8 months for Carboplatin, noting a p-value of 0.0038 from the log-rank test.*

FDA Label Image

Figure2 (Figure2)

This is a Kaplan-Meier curve comparing progression-free probability over time for gemcitabine for injection versus paclitaxel, showing median time to documented disease progression in months. The x-axis represents time in months to documented disease progression, and the y-axis represents progression-free probability. The graph includes sample sizes with 267 for gemcitabine/paclitaxel combination and 262 for paclitaxel alone.*

FDA Label Image

Figure3 (Figure3)

A Kaplan-Meier survival curve chart comparing survival probability over time (in months) between two treatment groups: Gemcitabine/Cisplatin (N=260) and Cisplatin alone (N=262). The graph plots survival probability versus survival time, showing higher survival probability for the Gemcitabine/Cisplatin group. Median survival is 9.0 months for the combination therapy and 7.6 months for Cisplatin alone. Also included are 1-year survival percentages and statistical test results (Logrank and Wilcoxon) with p-values.*

FDA Label Image

Figure4 (Figure4)

A survival curve chart comparing fraction surviving over time (in months) for two treatments: Gemcitabine for injection and 5-FU. The y-axis represents fraction surviving, ranging from 0 to 1, and the x-axis represents survival time in months, ranging from 0 to 20.*

FDA Label Image

Structure (Structure)

Chemical structure of gemcitabine hydrochloride, showing its molecular formula and arrangement of atoms including fluorine, oxygen, nitrogen, and hydrogen.*

* 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.