Oxaliplatin Injection, Solution
Product Images NDC 55150-331

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Oxaliplatin (NDC 55150-331). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Eugia Us Llc, 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 (Oxaliplatin Fig1)

Figure-1 (Oxaliplatin Fig1)
This appears to be a statistical analysis report of DFS (Disease-Free Survival) probability data with Hazard Ratio [95% CI] and Stratified Logrank Test results. The table shows the number of events, percentage, and number of patients at risk for two categories (AFOLFOX4, BILVSFU2) during a period of 72 months. Exact details and conclusions, however, cannot be determined without further information.*
FDA Label Image

Figure 2 (DFS Kaplan-Meier curves by treatment arm (cutoff: 1 June 2006) – ITT population)

Figure 2 (DFS Kaplan-Meier curves by treatment arm (cutoff: 1 June 2006) – ITT population)
This appears to be a statistical report related to DFS (Disease-Free Survival) probability. It includes a hazard ratio with confidence interval and a logrank test p-value. The data also lists treatment arms for FOLFOX4 and LV5FU2 in cases of Dukes C. However, the meaning and context of the numbers are unclear.*
FDA Label Image

Figure 3 (DFS Kaplan-Meier curves by treatment arm in Stage III patients (cutoff: 1 June 2006) – ITT population)

Figure 3 (DFS Kaplan-Meier curves by treatment arm in Stage III patients (cutoff: 1 June 2006) – ITT population)
This is a chart showing the percentage of patients surviving and the median survival in months for three different chemotherapy treatments. The treatments compared are: Oxaliplatin + 5-FU/LV, Oxaliplatin + Irinotecan, and Irinotecan + 5-FULV. The chart indicates that patients who received Oxaliplatin + 5-FU/LV had a median survival of 194 months, while those who received Oxaliplatin + Irinotecan had a median survival of 178 months, and those who received Irinotecan + 5-FULV had a median survival of 148 months.*
FDA Label Image

Figure 4 – Kaplan-meier Overall Survival By Treatment Arm (Oxaliplatin Fig4)

Figure 4 – Kaplan-meier Overall Survival By Treatment Arm (Oxaliplatin Fig4)
Oxaliplatin Injection, USP is a cytotoxic agent provided in a single dose vial of 50mg per 10mL (5mg/mL) for intravenous use only. It is a sterile, aqueous solution without any preservatives. Do not mix or add to sodium chloride/chloride-containing solutions. Each vial contains Oxaliplatin USP, 50mg, and Water for Injection, USP (10 mL). Usual dosage should be based on healthcare provider's prescription. It is manufactured in India for AuroMedics Pharma LLC, located at E. Windsor, NJ 08520. Storage conditions require temperatures between 20-25°C (68° to 77°F), with excursions between 15° to 30°C (59° to 86°F) permitted. The unused portion of the solution should be discarded and refer to the package insert for further diluted solutions. The code is TSORUGS4201S and P1423211.*
FDA Label Image

Package Label-principal Display Panel-50 mg Per 10 mL (5 mg/ml) (Container Label)

Package Label-principal Display Panel-50 mg Per 10 mL (5 mg/ml) (Container Label)
Oxaliplatin Injection, USP is a sterile, aqueous solution containing 50mg per 10ml (5mg/mL) for intravenous use only. Each vial is a single-dose vial and contains Oxaliplatin USP, 50mg and Water for Injection, USP (10 ml). This is a cytotoxic agent, it should not be mixed or added to sodium chloride/chloride-containing solutions. The usual dosage and instructions for storage and dilution can be found in the package insert. The vial stopper is not made with natural rubber latex. This product is distributed by AuroMedics Pharma LLC, made in India.*
FDA Label Image

Package Label-principal Display Panel-50 mg Per 10 mL (5 mg/ml) (Container-Carton (1 Vial))

Package Label-principal Display Panel-50 mg Per 10 mL (5 mg/ml) (Container-Carton (1 Vial))
This is a description of Oxaliplatin Injection, which is a medicine that should not be mixed or added to Sodium Chloride/Chloride-containing solutions. The NDC number is 55150-332.01 and each vial contains 100mg of Oxaliplatin USP and Water for Injection, USP (20 L). The medication is a sterile, aqueous solution that is preservative-free. It should be stored at room temperature, between 20° to 25°C (68°to 77°F), and protected from light. The medication comes in a single-dose vial and is for intravenous use only as a cytotoxic agent. The package insert should be consulted for further dilution requirements.*
FDA Label Image

Package Label-principal Display Panel-100 mg Per 20 mL (5 mg/ml) (Container Label)

Package Label-principal Display Panel-100 mg Per 20 mL (5 mg/ml) (Container Label)
This is information on the drug Oxaliplatin, which is available in a single-dose vial containing 100mg/20mL (5mg/mL) for intravenous use only. The drug should be stored at 20°C to 25°C and protected from light. Unused portions should be discarded according to the instructions provided in the package. It is a cytotoxic agent that should not be mixed with sodium chloride/chloride-containing solutions. The vial stopper is not made from natural rubber latex. The drug is distributed by AuroMedics Pharmaceuticals LLC, and it was made in India. The usual dosage is determined by the package insert.*
FDA Label Image

Chemical Structure (Oxaliplatin Str)

Chemical Structure (Oxaliplatin Str)

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