Gemcitabine Injection, Powder, Lyophilized, For Solution
Product Images NDC 63323-102

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 63323-102). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, 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

Gem0j 0002 01

Chemical structure diagram of gemcitabine showing its molecular components including aminopyrimidine, fluorinated sugar moiety, and hydrochloride (HCl) association.*

FDA Label Image

Gem0j 0002 02

Kaplan-Meier curve charting progression-free survival probability over time in months for two groups: Gemcitabine/Carboplatin and Carboplatin alone. The graph shows median progression-free survival values with corresponding statistical data including log-rank p-value.*

FDA Label Image

Gem0j 0002 03

A Kaplan-Meier curve chart depicting progression-free probability over time in months for Gemcitabine/Paclitaxel versus Paclitaxel alone. The chart compares time to documented disease progression, showing improved median progression-free time of 5.2 months for Gemcitabine/Paclitaxel and 2.9 months for Paclitaxel, with statistical significance (log-rank p < 0.0001).*

FDA Label Image

Gem0j 0002 04

A Kaplan-Meier survival curve chart showing survival probability over time in months for two groups: patients treated with Gemcitabine/Cisplatin and Cisplatin alone. The chart includes median survival times (9.0 months for Gem/Cis and 7.6 months for Cis) and 1-year survival rates (39% for Gem/Cis and 28% for Cis). Statistical test p-values for Logrank and Wilcoxon tests are also shown.*

FDA Label Image

Gem0j 0002 05

A survival curve chart comparing fraction surviving over time (months) for Gemcitabine versus 5-FU. The x-axis shows survival time in months, and the y-axis shows the fraction surviving, with Gemcitabine demonstrating a higher survival fraction over time compared to 5-FU.*

FDA Label Image

Gem0j 0002 06

FDA Label Image

Gem0j 0002 07

Label for Gemcitabine for Injection, USP 200 mg per vial, a single-dose vial labeled for intravenous use only. The product is described as sterile and lyophilized, with storage instructions and dilution requirements noted. The labeler is APP Pharmaceuticals, LLC, and the label states the product is cytotoxic and for prescription use only. Branding includes the Fresenius Kabi logo.*

FDA Label Image

Gem0j 0002 08

Label for Gemcitabine injection, USP, 200 mg per vial for intravenous use. The label states the vial is single-dose and must be diluted. It includes details about the drug's contents, storage instructions, and is labeled by Fresenius Kabi, Lake Zurich, IL.*

FDA Label Image

Gem0j 0002 09

Packaging label for Gemcitabine for Injection, USP, 1 g per vial. The label includes dosing and reconstitution instructions, storage requirements (store at 20° to 25°C), cautionary statements about cytotoxicity, and distributor information for Fresenius Kabi in Lake Zurich, IL. The label also features the NDC 63323-125-53 and a barcode.*

FDA Label Image

Gem0j 0002 10

Gemcitabine for Injection, USP 1 g per vial single-dose vial label. The label indicates it is sterile, lyophilized for intravenous use only, must be diluted before administration. The labeler is Fresenius Kabi under APP Pharmaceuticals, LLC. The label includes dilution instructions and storage conditions, with a barcode and lot/expiration fields.*

FDA Label Image

Gem0j 0002 11

Label for Gemcitabine injection, USP 2 g per vial, single-dose vial for intravenous use only. The label states the product must be diluted and not refrigerated. It is labeled as a cytotoxic agent and Rx only. The labeler is Fresenius Kabi, Lake Zurich, IL. Storage instructions specify 20° to 25°C (68° to 77°F).*

FDA Label Image

Gem0j 0002 12

Gemcitabine for Injection, USP 2 g per vial label by APP Pharmaceuticals, LLC. The label states it is sterile, lyophilized, for intravenous use only, and must be diluted before administration. It is a single-dose vial and includes instructions for reconstitution and storage. The label shows a barcode and the Fresenius Kabi logo.*

* 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.