Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution
Product Images NDC 68083-148

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Gemcitabine Hydrochloride (NDC 68083-148). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Gland Pharma Limited, 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

Gemcitabine-spl-image1 (Gemcitabine Spl Image1)

Chemical structure of gemcitabine hydrochloride, showing its molecular arrangement with a pyrimidine base and a sugar moiety including fluorine atoms and a hydrochloride group.*

FDA Label Image

Gemcitabine-spl-image2 (Gemcitabine Spl Image2)

A Kaplan-Meier survival curve comparing progression-free survival probabilities over time in months between Gemcitabine/Carboplatin and Carboplatin alone. The graph shows higher progression-free survival for Gemcitabine/Carboplatin (N=178) compared to Carboplatin (N=178), with median progression-free survival of 8.6 months versus 5.8 months, respectively, and a log-rank p-value of 0.0038.*

FDA Label Image

Gemcitabine-spl-image3 (Gemcitabine Spl Image3)

A Kaplan-Meier curve graph displaying progression-free probability over time in months for two treatment groups: Gemcitabine/Paclitaxel (N=267) and Paclitaxel alone (N=262). The graph shows that median time to documented disease progression is longer for the Gemcitabine/Paclitaxel group (5.2 months) compared to Paclitaxel alone (2.9 months), with a log-rank p-value less than 0.0001.*

FDA Label Image

Gemcitabine-spl-image4 (Gemcitabine Spl Image4)

A Kaplan-Meier survival curve graph showing survival probability over time (months) comparing gemcitabine/cisplatin versus cisplatin treatment groups. The graph includes median survival times (9 months for gemcitabine/cisplatin, 7.6 months for cisplatin), 1-year survival percentages (39% and 28%, respectively), and p-values for Logrank (0.008) and Wilcoxon (0.018) tests.*

FDA Label Image

Gemcitabine-spl-image5 (Gemcitabine Spl Image5)

A survival time chart comparing Gemcitabine and 5-FU treatments. The y-axis shows the fraction surviving from 0.0 to 1.0, and the x-axis indicates survival time in months from 0 to 20. The graph shows Gemcitabine with a higher survival fraction over time compared to 5-FU.*

FDA Label Image

Gemcitabine-spl-vial-label-200-mg (Gemcitabine Spl Vial Label 200 mg)

Label for Gemcitabine for Injection, USP 200 mg per vial, lyophilized powder for intravenous injection. The single-dose vial label indicates it must be reconstituted and further diluted, is for intravenous use only, and should not be refrigerated. It includes a caution that it is a cytotoxic agent. The label shows NDC 68083-148-01 and is manufactured by Gland Pharma Limited, Visakhapatnam, India.*

FDA Label Image

Gemcitabine-spl-carton-label-200-mg (Gemcitabine Spl Carton Label 200 mg)

Carton label for Gemcitabine for Injection, USP 200 mg per vial, lyophilized powder for injection, manufactured by Gland Pharma Limited. The label includes reconstitution instructions, cautions about cytotoxicity, storage requirements (20 to 25°C), and a barcode. It is for single-dose vials intended for intravenous use only and must not be refrigerated.*

FDA Label Image

Gemcitabine-spl-vial-label-1-g (Gemcitabine Spl Vial Label 1 G)

The label for Gemcitabine for Injection, USP 1 gram per vial, lyophilized powder for injection by intravenous use. It labels the product as sterile, single-dose, and highlights storage instructions, reconstitution directions, and cautions as a cytotoxic agent. The label includes the manufacturer Gland Pharma Limited and specifies the NDC 68083-149-01.*

FDA Label Image

Gemcitabine-spl-carton-label-1-g (Gemcitabine Spl Carton Label 1 G)

Label for Gemcitabine for Injection, USP 1 gram per vial, a sterile, lyophilized powder for injection by intravenous use. The label includes cautions for cytotoxicity, storage instructions, and manufacturer information for Gland Pharma Limited, India. The vial must be reconstituted and further diluted before use and is single-dose only.*

* 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.