Sunitinib Malate Capsule
Product Images NDC 59651-464

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Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Sunitinib Malate (NDC 59651-464). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma 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

Figure (Sunitinib Fig1)

Figure (Sunitinib Fig1)
This text provides data on the time to tumor progression probability using Sunitinib Malate compared to Placebo. Sunitinib Malate (N=207) showed a median of 27.3 weeks compared to Placebo (N=105) with a median of 6.4 weeks. The Hazard Ratio was 0.33 with a 95% confidence interval of (0.23, 0.47) and a p-value of <0.0001. The graph displays the progression probability over time in weeks.*
FDA Label Image

Package Label-principal Display Panel (37.5 mg 28 Capsules (4 x 7 Unit-Dose))

Package Label-principal Display Panel (37.5 mg 28 Capsules (4 x 7 Unit-Dose))
This is a description for Sunitinib Malate Capsules which contains 37.5 mg of sunitinib equivalent to 50.12 mg of sunitinib malate. The dosage and use instructions are detailed in the accompanying prescribing information. The capsules should be stored at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F). This product comes in a 28 capsules unit-dose package and is not child resistant. Additional medication guides can be printed from the provided website.*
FDA Label Image

Package Label-principal Display Panel (50 mg (28 Capsules Bottle))

Package Label-principal Display Panel (50 mg (28 Capsules Bottle))
This text provides information about a medication capsule containing 50 mg of sunitinib malate, distributed by Aurobindo Pharma USA, Inc. The capsule is made in India and should be stored at 20°C to 25°C. It also includes details for pharmacists to dispense the medication and to provide a medication guide to each patient. The prescription is for 28 capsules in tight containers. For more information, access the medication guides on the Aurobindo website.*
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Package Label-principal Display Panel (50 mg 28 28 Capsules (4 x 7 Unit-Dose))

Package Label-principal Display Panel (50 mg 28 28 Capsules (4 x 7 Unit-Dose))
This is a description of sunitinib malate capsules, each containing 50 mg of sunitinib equivalent to 66.83 mg sunitinib malate. The dosage and use information can be found in the accompanying prescribing information. The capsules should be stored at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F). This unit-dose package is not child-resistant. The medication guides can be printed from the provided website. The package contains 28 capsules in a unit-dose format, with instructions for the pharmacist to dispense the medication guide to each patient. The product is distributed by Aurobindo Pharma USA, Inc, and made in India.*
FDA Label Image

Figure (Sunitinib Fig2)

Figure (Sunitinib Fig2)
This text provides statistical data comparing the time to tumor progression probability between Sunitinib Malate and Placebo treatments. The results show that the median time for tumor progression was 27.3 weeks for Sunitinib Malate compared to 6.4 weeks for Placebo. The Hazard Ratio was 0.33 with a 95% confidence interval ranging from 0.23 to 0.47. The statistical significance was indicated as p < 0.0001.*
FDA Label Image

Figure (Sunitinib Fig3)

Figure (Sunitinib Fig3)
This is a comparison of disease-free survival probability between Sunitinib Malate and Placebo over a median follow-up period of 6.8 years and 5.6 years, respectively, involving 309 and 306 subjects, with hazard ratio, 95% confidence interval, and P-value provided. The number of subjects at risk at different time points is also shown for both treatment groups.*
FDA Label Image

Figure (Sunitinib Fig4)

Figure (Sunitinib Fig4)
Description: The document provides statistical data related to Progression Free Survival Probability comparison between Sunitinib Malate (N=86) and Placebo (N=85) groups. It shows a Hazard Ratio of 0.427 with a 95% Confidence Interval ranging from 0.271 to 0.673. The Median Progression Free Survival for Sunitinib Malate group is 10.2 months, whereas for the Placebo group, it is 5.4 months. The information also includes the number of subjects at risk over time for both groups.*
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Package Label-principal Display Panel (12.5 mg (28 Capsules Bottle))

Package Label-principal Display Panel (12.5 mg (28 Capsules Bottle))
This text provides information about Sunitinib Malate Capsules with a National Drug Code (NDC) number 59651-464-28. The medication is dispensed with a Medication Guide, and each capsule contains 12.5 mg of sunitinib equivalent to 16.71 mg of sunitinib malate. It is recommended to store the capsules at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F). The medication is distributed by Aurobindo Pharma USA, Inc., with manufacturing in India. For dosage and usage information, refer to the accompanying prescribing information.*
FDA Label Image

Package Label-principal Display Panel (12.5 mg 28 Capsules (4 x 7 Unit-Dose))

Package Label-principal Display Panel (12.5 mg 28 Capsules (4 x 7 Unit-Dose))
This is a description of Sunitinib Malate Capsules. Each capsule contains 12.5 mg sunitinib equivalent to 16.71 mg sunitinib malate. It is recommended to store them at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). The package is not child-resistant and should be dispensed with a Medication Guide provided separately to each patient. These capsules are available in a unit-dose package containing 28 capsules (4 x 7 Unit-Dose). Made in India, the product is for prescription use only. Pharmacies can access Medication Guides online at the Aurobindo website.*
FDA Label Image

Package Label-principal Display Panel (25 mg 28 Capsules (4 x 7 Unit-Dose))

Package Label-principal Display Panel (25 mg 28 Capsules (4 x 7 Unit-Dose))
This is a prescription drug package for Sunitinib Malate capsules containing 25 mg of sunitinib equivalent to 33.41 mg sunitinib malate. The medication guide should be dispensed to each patient. The dosage and usage instructions are found in the accompanying prescribing information. The capsules should be stored between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). The drug is distributed by Aurobindo Pharma USA, Inc. and was made in India.*
FDA Label Image

Package Label-principal Display Panel (25 mg 28 Capsules (4 x 7 Unit-Dose))

Package Label-principal Display Panel (25 mg 28 Capsules (4 x 7 Unit-Dose))
The text provides information about Sunitinib Malate Capsules containing 25 mg of sunitinib, equivalent to 33.41 mg of sunitinib malate. It mentions dosage and usage instructions, storage conditions, and the fact that the unit-dose package is not child-resistant. Pharmacists are advised to dispense the Medication Guide separately to each patient. The capsules come in a pack of 28 (4 x 7 unit-dose) and are available by prescription only. The manufacturer's information includes Aurobindo USA, with the address at 279 Princeton-Hightstown Road, East Windsor, NJ 08520, and the capsules are made in India. More details can be found at the website www.aurobindousa.com/medication-guides.*
FDA Label Image

Package Label-principal Display Panel (37.5 mg (28 Capsules Bottle))

Package Label-principal Display Panel (37.5 mg (28 Capsules Bottle))
This text provides information about capsules containing 37.5 mg of sunitinib equivalent to 50.12 mg of sunitinib malate, distributed by Aurobindo Pharma USA, Inc. It includes details such as the NDC number, storage instructions, and a reference to prescribing information. The text also instructs pharmacists to dispense the medication in tight containers and mentions providing a medication guide to each patient. The capsules are made in India and the full prescribing information can be found on the Aurobindo website.*
FDA Label Image

Str (Sunitinib Str)

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