Gemcitabine Injection, Powder, Lyophilized, For Solution
Product Images NDC 16714-909

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 16714-909). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northstar Rx 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

Gem0h 0001 01

Chemical structure of gemcitabine hydrochloride showing its molecular arrangement including amine, hydroxyl, fluorine, and ketone functional groups within the nucleoside analogue.*

FDA Label Image

Gem0h 0001 02

A Kaplan-Meier plot showing median progression-free survival for two treatments: Gemcitabine for Injection with Carboplatin (N=178) and Carboplatin alone (N=178). The y-axis shows progression-free probability, and the x-axis shows progression-free survival in months, up to 42 months. Median survival times are 8.6 months for Gemcitabine/Carboplatin and 5.8 months for Carboplatin. A P-value of 0.0038 indicates statistical comparison by log rank test.*

FDA Label Image

Gem0h 0001 03

A Kaplan-Meier survival curve chart showing progression-free probability over time in months to documented disease progression comparing Gemcitabine for Injection/Paclitaxel versus Paclitaxel alone. The chart includes median progression times and a statistical log-rank p-value for comparison.*

FDA Label Image

Gem0h 0001 04

A Kaplan-Meier survival curve comparing survival probability over time (months) between patients treated with Cisplatin and those treated with Gemcitabine/Cisplatin. The graph shows median survival times and 1-year survival percentages for each group, alongside statistical test values including Logrank and Wilcoxon p-values.*

FDA Label Image

Gem0h 0001 05

A survival curve chart comparing survival time in months on the x-axis with the fraction surviving on the y-axis. It depicts two lines labeled "Gemcitabine for injection" and "5-FU," showing comparative survival rates over time.*

FDA Label Image

Gem0h 0001 06

Label for Gemcitabine injection, USP, 200 mg/vial, a lyophilized powder for intravenous use. It is a sterile single-dose vial and cytotoxic agent. The label includes reconstitution instructions, storage conditions, manufacturer details (NorthStar Rx LLC), and a barcode with NDC 16714-909-01.*

FDA Label Image

Gem0h 0001 07

Packaging label for Gemcitabine 200 mg/vial, an injection powder, lyophilized, for intravenous use. The label indicates it is a sterile, single-dose vial that must be reconstituted and further diluted. It is labeled as a cytotoxic agent and manufactured for NorthStar Rx LLC. The label includes handling cautions, storage instructions, and manufacturing details, including manufacturing in India by Kindos Pharmaceuticals Co., Ltd.*

FDA Label Image

Gem0h 0001 08

Gemcitabine 1 g/vial for Injection, USP, powder lyophilized for intravenous use. The label states it is a sterile single-dose vial and cytotoxic agent that must be reconstituted and further diluted before use. Storage instructions specify not to refrigerate and to store at controlled room temperature. Manufactured for Northstar Rx LLC.*

FDA Label Image

Gem0h 0001 09

Packaging label for Gemcitabine Injection, USP 1 g/vial, a lyophilized powder for solution intended for intravenous use. The label indicates it is a sterile, single-dose vial, cytotoxic agent, and must be reconstituted and diluted before use. Manufactured for NorthStar Rx LLC and produced by Kindos Pharmaceuticals Co., Ltd. in China. The label includes handling and storage instructions, cautions, and barcode information.*

* 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.