Gemcitabine Hydrochloride Injection, Powder, Lyophilized, For Solution
Product Images NDC 82511-009

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Gemcitabine Hydrochloride (NDC 82511-009). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Teyro Labs Private 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

Image Description (Gemcitabine Hydrochloride 1g Carton Label)

This is a description of Gemcitabine, a cytotoxic agent for injection used intravenously. It is a sterile single-dose vial that should not be refrigerated. Each vial contains gemcitabine hydrochloride expressed as the free base, along with other components. The usual dosage instructions are provided in the package insert. Prior to and after reconstitution, it should be stored at controlled room temperature. The reconstitution process involves adding sodium chloride injection to make a solution, which should be administered within 24 hours of preparation. The product is manufactured by Teyro Labs Private Limited in Tamil Nadu, India.*

FDA Label Image

Image Description (Gemcitabine Hydrochloride 1g Vial Label)

This text provides instructions for the use and administration of Gemcitabine, a cytotoxic agent used for intravenous injection. It includes details about the contents of the vial, storage conditions, reconstitution process, dosage information, and manufacturer details. The text also emphasizes the importance of following package insert guidelines and not refrigerating the medication.*

FDA Label Image

Image Description (Gemcitabine Hydrochloride 200mg Carton Label)

Gemcitabine is a sterile, lyophilized powder for injection used as a cytotoxic agent in the treatment of certain cancers. The single-dose vial contains Gemcitabine HCl, with each vial containing 200 mg of gemcitabine. The product should not be refrigerated and must be stored between 20°C to 25°C. To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection and shake to dissolve. The solution should be administered intravenously within 24 hours. Manufacturer: Teyro Labs Private Limited, located in Tamil Nadu, India.*

FDA Label Image

Image Description (Gemcitabine Hydrochloride 200mg Vial Label)

This text provides information about a medication with the NDC 82511-008-20 indicated for injection use only. The vial contains 200 mg of gemcitabine, 200 mg of mannitol, and 12.5 mg of sodium acetate. It instructs to not refrigerate and store between 20°C to 25°C. The medication needs to be reconstituted by adding 5 mL of 0.9% Sodium Chloride Injection. The solution needs to be administered within 24 hours and any unused portion should be discarded. It warns that it is a cytotoxic agent manufactured by Teyro Labs Private Limited in Tamil Nadu, India.*

FDA Label Image

Image Description (Gemcitabine Hydrochloride Graph 1)

This text provides information about the median progression-free survival for two different treatments - Gemzar/Carboplatin and Carboplatin. The text shows that the median progression-free survival for Gemzar/Carboplatin is 8.6 months while for Carboplatin it is 5.8 months, with a significant difference indicated by a log rank p-value of 0.0038. The data is based on a sample size of 178 for each treatment. The graph shows the progression-free survival over time (in months) for both treatments.*

FDA Label Image

Image Description (Gemcitabine Hydrochloride Graph 2)

This text provides data on the Progression-Free Probability and Median Time to Documented Disease Progression for two treatments: Gemzar/Paclitaxel (5.2 months) and Paclitaxel (2.9 months). The analysis shows a statistically significant difference (p<0.0001) between the two treatments. The graph displays the time to documented disease progression in months for each treatment group.*

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Image Description (Gemcitabine Hydrochloride Graph 3)

This is a comparison of survival probabilities between Gemcitabine/Cisplatin treatment and Cisplatin treatment based on median survival and 1-year survival rates. The data includes survival times in months, with Gem/Cis having a median survival of 9.0 months and 39% 1-year survival rate, while S Cis has a median survival of 7.6 months and 28% 1-year survival rate. The p-values for the comparison are Logrank: 0.008 and Wilcoxon: 0.018.*

FDA Label Image

Image Description (Gemcitabine Hydrochloride Graph 4)

FDA Label Image

Image Description (Gemcitabine Hydrochloride Structure)

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