Gemcitabine
Product Images NDC 68001-342

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 68001-342). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bluepoint 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

Gemcitabine Rtu 1.5g_15ml Carton (Gemcitabine 15g 15ml Carton)

Label for Gemcitabine Injection 1.5 g/15 mL (100 mg/mL) by BluePoint Laboratories. The sterile multiple-dose vial is for intravenous infusion and must be diluted before use. The label includes dosage and handling cautions, storage instructions, manufacturer details (Intas Pharmaceuticals Limited, India), and barcodes.*

FDA Label Image

Gemcitabine Rtu 1.5g_15ml Vial Label (Gemcitabine 15g 15ml Container)

This label for Gemcitabine Injection includes dosage instructions, storage conditions, and manufacturing details. The product strength is 1.5 g/15 mL (100 mg/mL) for intravenous infusion only, requiring dilution before use. It is labeled for multiple dose vial use, with storage recommended at 20 to 25°C and a discard timeframe of 28 days after initial puncture. The manufacturer is Intas Pharmaceuticals Limited for BluePoint Laboratories.*

FDA Label Image

Gemcitabine Rtu 1g_10ml Carton (Gemcitabine 1g 10ml Carton)

Packaging label for Gemcitabine injection by BluePoint Laboratories with a concentration of 1 g/10 mL (100 mg/mL). The label includes dosage form instructions, cautions as a cytotoxic agent, storage information, and manufacturer details (Intas Pharmaceuticals Limited, India). The label indicates it is a sterile, multiple-dose vial for intravenous infusion only, with instructions to dilute before use and discard 28 days after initial puncture.*

FDA Label Image

Gemcitabine Rtu 1g_10ml Vial Label (Gemcitabine 1g 10ml Container)

Label for Gemcitabine Injection 1 g/10 mL (100 mg/mL) by BluePoint Laboratories. The label indicates intravenous infusion use and requires dilution before use. It is a multiple dose vial of 10 mL. Storage instructions specify 20°C to 25°C, and it should not be refrigerated. Manufactured by Intas Pharmaceuticals Limited in India.*

FDA Label Image

Gemcitabine Rtu 200mg_2ml Carton (Gemcitabine 200mg 2ml Carton)

Label for Gemcitabine Injection by BluePoint Laboratories displaying 200 mg per 2 mL (100 mg/mL) strength. The label indicates it is for intravenous infusion only, must be diluted before use, and cautions it as a cytotoxic agent. The vial size is 2 mL sterile multiple dose. Manufacturer details show Intas Pharmaceuticals in India.*

FDA Label Image

Gemcitabine Rtu 200mg_2ml Vial (Gemcitabine 200mg 2ml Container)

Label for Gemcitabine Injection 200 mg/2 mL (100 mg/mL) by BluePoint Laboratories. It is a 2 mL multiple dose vial intended for intravenous infusion only and must be diluted before use. The label includes storage instructions, a barcode, and space for batch coding information.*

FDA Label Image

Gemcitabine Rtu 2g_20ml Carton (Gemcitabine 2g 20ml Carton)

Packaging label for Gemcitabine injection 2 g/20 mL (100 mg/mL) by BluePoint Laboratories. The multiple dose vial is for intravenous infusion only and must be diluted before use. The label includes storage instructions, a cytotoxic agent caution, and manufacturing details from Intas Pharmaceuticals Limited, India.*

FDA Label Image

Gemcitabine Rtu 2g_20ml Vial Label (Gemcitabine 2g 20ml Container)

This is a drug label for Gemcitabine Injection 2 g/20 mL (100 mg/mL) in a 20 mL multiple dose vial. It is labeled for intravenous infusion and must be diluted before use. The label includes storage instructions to keep at 20ºC to 25ºC and not to refrigerate. It is manufactured by Intas Pharmaceuticals Limited for BluePoint Laboratories and features a barcode and revision date of 07/2019.*

FDA Label Image

Structural Formula (Gemcitabine F01 V1)

Chemical structure of gemcitabine hydrochloride shown as a molecular diagram with labeled atoms and bonds representing its nucleoside analog structure.*

FDA Label Image

Figure 2 (Gemcitabine F02 V1)

A Kaplan-Meier curve chart showing median time to documented disease progression comparing Gemcitabine/Paclitaxel combination therapy to Paclitaxel alone. The x-axis represents time in months, and the y-axis shows progression-free probability. Gemcitabine/Paclitaxel has a median progression time of 5.2 months, and Paclitaxel alone has 2.9 months, with a significant log-rank p value less than 0.0001.*

FDA Label Image

Figure 3 (Gemcitabine F03 V1)

A Kaplan-Meier survival curve comparing survival probabilities over time in months for two groups: Gemcitabine/Cisplatin (N=260) and Cisplatin alone (N=262). The graph shows higher median and 1-year survival rates for the Gemcitabine/Cisplatin group, with statistical significance indicated by Logrank and Wilcoxon test p-values.*

FDA Label Image

Figure 4 (Gemcitabine F04 V1)

A survival curve chart comparing fraction surviving over survival time in months, showing two lines labeled Gemcitabine and 5-FU. The x-axis is survival time in months, and the y-axis is fraction surviving from 0.0 to 1.0.*

FDA Label Image

Figure 1 (Gemcitabine F05 V1)

Kaplan-Meier curve depicting progression-free survival probabilities over time in months, comparing Gemcitabine plus Carboplatin versus Carboplatin alone for a sample size of 178 in each group. The graph includes median progression-free survival times for both treatments and a log-rank p-value.*

* 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.