Gemcitabine
Product Images NDC 55390-391

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 55390-391). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bedford 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

1carton (1carton)

1carton (1carton)
Gemcitabine for Injection is a sterile, lyophilized, single-use vial that is used for intravenous use only. The medication must not be refrigerated and must be diluted before use. Gemcitabine is a cytotoxic agent that is only available with a prescription, and each vial contains sodium acetate trihydrate, hydrochloric acid, and/or sodium hydroxide that may be used to adjust its pH. The manufacturer advises caution when handling and using the solution to prevent particle formation. It is stored at room temperature until and after reconstitution. The solution is usually prepared by adding 25 mL of a 0.5% Sodium Chloride injection to the vial to make a solution containing 38 mg/mL, shaken for administration, and used within 24 hours. Any unused solution should be discarded.*
FDA Label Image

1vial (1vial)

1vial (1vial)
Gemcitabine is a cytotoxic agent that must be diluted for intravenous use only. Each vial contains Gemcitabine HCI USP. The recommended adult dose should be directed by healthcare professionals. To reconstitute the vial, add 25mL of 0.9% Sodium Chloride. This will make a solution containing 38mg/mL. The solution should be shaken and administered within 24 hours. The unused portion should be discarded. Gemcitabine should be stored at 20°C to 25°C and not refrigerated. This product is distributed by Bedford Laboratories™ in Bedford, OH.*
FDA Label Image

200carton (200carton)

200carton (200carton)
This appears to be product information for Gemcitabine, a cytotoxic agent used for intravenous administration only. The drug is packaged in sterile single-use vials and must be diluted before use. Storage should be at room temperature. The text provides instructions on how to prepare the drug for IV administration and usual adult dosing quantities. The manufacturer is Dr. Redidy's Laboratories Ltd. and it is distributed by Bedford Laboratories. Made in India.*
FDA Label Image

200vial (200vial)

200vial (200vial)
Gemcitabine is a cytotoxic agent used for intravenous use in adults as an alternative treatment. Each single-use vial contains 200mg of Gemcitabine which requires reconstitution with sterile water prior to administration. The product must be stored at room temperature and must not be refrigerated. The accompanying text also includes information regarding the dosage, contraindications, and storage instructions.*
FDA Label Image

Figure1 (Figure1)

FDA Label Image

Figure2 (Figure2)

FDA Label Image

Figure3 (Figure3)

Figure3 (Figure3)
This text appears to be reporting some statistics related to survival rates and probability in patients receiving Gemcitabine and Cisplatin chemotherapy. The survival rates reported are 9.0 months for Gem/Cis and 7.6 months for Cis alone. The statistical significance of these differences is reported with a Logrank of 0.008 and a Wilcoxon of 0.018. A survival probability graph is also included.*
FDA Label Image

Figure4 (Figure4)

FDA Label Image

Structure (Structure)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.