Oxaliplatin
Product Images NDC 47335-178

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Oxaliplatin (NDC 47335-178). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

Product Images & Figures Index

FDA Label Image

Figure-1 (Figure 1)

Figure-1 (Figure 1)
FDA Label Image

Figure-2 (Figure 2)

Figure-2 (Figure 2)
The provided text contains a graph showing the DFS (disease-free survival) Kaplan-Meier curves by treatment arm, divided into two groups labeled FOLFOX4 and LVSFL2. The Hazard Ratio is 0.8 and the Stratified Logrank Test has a p-value of 0.003, indicating a statistically significant difference between the two groups. The graph spans 72 months and shows the number of events as a percentage for each group.*
FDA Label Image

Figure-3 (Figure 3)

Figure-3 (Figure 3)
This document appears to be a statistical analysis report with a focus on DFS (disease-free survival) probability in patients with Dukes C stage of cancer. The report presents data on Hazard Ratio, Logrank test, and Kaplan-Meier curves, as well as corresponding p-values for FOLFOX4 and LV5FU2 treatment arms. The data is specifically relevant to Stage Il (not one or three, just "Il") patients and the ITT population. The document includes a graph, but there is not enough information to provide a detailed summary of its contents.*
FDA Label Image

Figure-4 (Figure 4)

Figure-4 (Figure 4)
The text shows a graph labeled "Figure 4- Kaplan-Meier Overall Survival by treatment arm" comparing the median survival rates of three treatments: Oxaliplatin for Injection + 5-FU/LV, Oxalplatin or Injection + Irinotecan, and Irinotecan + 5-FULV. The x-axis denotes the number of months, while the y-axis shows the percentage of patients surviving. The log-rank test compares Oxaliplatin for Injection plus 5-FU/LV to Irinotecan plus 5-FU/LV. The output is readable.*
FDA Label Image

Label-100mg (Label 100mg)

Label-100mg (Label 100mg)
This is a description of a medication called Oxaliplatin, USP. The medication is a sterile lyophilized powder, presented in a single-use vial. The vial includes 100 mg of oxaliplatin, USP, and 900 mg of lactose monohydrate NF. The medication is a cytotoxic agent intended for intravenous use only. The usual dosage and instructions for reconstitution and further dilution can be found in the package insert. The medication should be stored between 20-25°C (68-77°F) with excursions permitted between 15-30°C (59-86°F). The unused portion should be discarded, and the medication must be reconstituted and diluted before use. Users should not reconstitute with sodium chloride/chloride-containing solutions. This medication is distributed by Sun Pharmaceutical Industries, Inc in Cranbury, NJ, and manufactured by Sun Pharmaceutical Ind. Ltd. in Halol-Baroda Highway, Halol-389 350, Gujarat, India, under license from Sanofi-Aventis U.S. LLC, Sanofi-Aventis, and Debiopharm S.A. of U.S. Pat Nos. 5,420,319 and 5,959,133.*
FDA Label Image

Label-50mg (Label 50mg)

Label-50mg (Label 50mg)
FDA Label Image

Chemical Structure (Oxaliplatin Struct)

Chemical Structure (Oxaliplatin Struct)
FDA Label Image

Showbox-100mg (Showbox 100mg)

Showbox-100mg (Showbox 100mg)
Oxaliplatin is a cytotoxic agent that comes in a single-use vial as a sterile lyophilized powder with no preservatives. Each vial contains 100 mg of oxaliplati, USP along with 900 mg of lactose monohycrate NF. Prior to reconstitution, it should be stored at 20C to 25C. Reconstitution should be with 20 mL of Water for Inection, USP or 5% Dextrose Injection, USP. The package insert contains dosage and dilution instructions. Unused portions should be discarded, and the storage guidelines for reconstituted and diluted solutions should be followed. This product is distributed by Sun Pharmaceutical Industries and manufactured by Sun Pharmaceutical Ind. Lid, under licence from Sanofi-Aventis U.S.LLC and Debiopharm A, of LS. Pat Nos. 5,420,319 and 5,959,133. It should be used intravenously only.*
FDA Label Image

Showbox-50mg (Showbox 50mg)

Showbox-50mg (Showbox 50mg)
This is a product description for Oxaliplatin for Injection, USP, a chemotherapeutic agent that comes in a single-use vial. It is a sterile lyophilized powder, free of preservatives, that must be reconstituted and diluted prior to use. The product is meant for intravenous use only and should not be reconstituted with sodium chloride/chloride-containing solutions. The inactive ingredient in each vial is lactose monohydrate NF 450 mg, and each vial contains 50 m of oxaliplatin, USP. The package insert contains information on dosage and administration. The product should be stored between 15°C and 30°C, and unused portions should be discarded. The product is distributed by Sun Pharmaceutica Industries, I, Cranbury, W08512 and manufactured by Sun Pharmaceutica Ind. Ltd. in India. The batch number and expiration date can be found on the box or vial.*

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