Gemcitabine Injection, Powder, Lyophilized, For Solution
Product Images NDC 25021-235

7 FDA label images from Sagent Pharmaceuticals · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 25021-235). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sagent Pharmaceuticals, 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

Gem09 0007 01

Gem09 0007 01
Chemical structure of gemcitabine hydrochloride, showing the molecular arrangement of atoms including fluorine, nitrogen, oxygen, and hydrogen elements characteristic of the active ingredient gemcitabine used in this pharmaceutical product.*
FDA Label Image

Gem09 0007 02

Gem09 0007 02
A Kaplan-Meier curve depicting median progression-free survival in months for two treatment groups: Gemcitabine/Carboplatin and Carboplatin alone. The y-axis shows progression-free probability, while the x-axis shows progression-free survival time in months. The graph includes median survival times and a statistical comparison (log rank p=0.0038).*
FDA Label Image

Gem09 0007 03

Gem09 0007 03
Kaplan-Meier plot showing progression-free probability over time in months for two treatments: Gemcitabine/Paclitaxel (N=267) and Paclitaxel alone (N=262). The x-axis represents time to documented disease progression, and the y-axis represents progression-free probability. Median progression times are 5.2 months for Gemcitabine/Paclitaxel and 2.9 months for Paclitaxel, with a statistically significant difference (log rank p<0.0001).*
FDA Label Image

Gem09 0007 04

Gem09 0007 04
A Kaplan-Meier survival curve chart comparing the survival probability over time (months) for two groups: Gemcitabine/Cisplatin (N=260) and Cisplatin alone (N=262). The graph shows survival probabilities on the y-axis and survival time in months on the x-axis. Median survival times and 1-year survival percentages are noted for both groups, with statistical test results including logrank and Wilcoxon p-values shown.*
FDA Label Image

Gem09 0007 05

Gem09 0007 05
A Kaplan-Meier survival curve comparing gemcitabine and 5-FU. The graph shows fraction surviving on the vertical axis and survival time in months on the horizontal axis, depicting a higher survival fraction over time for gemcitabine compared to 5-FU.*
FDA Label Image

Gem09 0007 06

Gem09 0007 06
Label for Gemcitabine for Injection, USP 200 mg per vial, lyophilized powder for intravenous use. The label states the product is sterile, nonpyrogenic, preservative-free, and must be reconstituted and further diluted prior to intravenous infusion. It includes a caution that it is a cytotoxic agent. Manufactured by Sagent Pharmaceuticals, Schaumburg, IL, made in China. Storage instructions specify not to refrigerate and to store at 20° to 25°C.*
FDA Label Image

Gem09 0007 07

Gem09 0007 07
Label for Gemcitabine for Injection, USP, 1 gram per vial. This lyophilized powder for solution is for intravenous use only and must be reconstituted and further diluted to single-dose vial. The label warns that this is a cytotoxic agent. It is produced by Sagent Pharmaceuticals, with the NDC 25021-235-50, and includes instructions for proper dilution, storage, and handling.*

* 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.