Lenalidomide Capsule
Product Images NDC 16729-697

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Lenalidomide (NDC 16729-697). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare 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.

FDA Label Image

10mg-28capsules (Lenalidomide 10mg Label)

The text is a label for Lenalidomide capsules warning about the potential for fetal defects and providing information on the content of the capsules, storage conditions, manufacturer details, and coding/serialization instructions. It advises storing the capsules at 20-25°C, with excursions permitted between 15-30°C, and emphasizes consulting the prescribing information for proper dosing and administration guidelines. The capsules contain 10 mg of Lenalidomide and are manufactured by Accord Healthcare Inc in India. The label includes a lot number, expiration date, and dimensions for coding/serialization purposes.*

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15mg-21capsules (Lenalidomide 15mg Label)

This text provides important information about lenalidomide capsules, including a warning about the potential for human birth defects, dosage instructions, storage requirements, and a link to the Medication Guide. The capsules contain 15 mg of lenalidomide and should be stored at 20°C to 25°C. It also indicates that the product is manufactured for Accord Healthcare Inc. and is a product of India.*

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2_5mg-28capsules (Lenalidomide 2 5mg Label)

This text is an evaluation of Lenalidomide capsules, containing 2.5 mg per capsule, with a warning about the potential for human birth defects. The capsules should be stored at a temperature between 20°C to 25°C (68°F to 77°F). It is recommended to refer to prescribing information for dosing and administration details. The product is manufactured for Accord Healthcare Inc. in Raleigh, NC, and is a product of India. There is information provided on lot number, expiration date, and size.*

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20mg-21capsules (Lenalidomide 20mg Label)

This is information about Lenalidomide capsules, with each capsule containing 20 mg of Lenalidomide. It is important to be cautious as there is a warning about the potential for human birth defects. The medication guide is available online, and it is recommended to refer to the prescribing information for dosing and administration details. The capsules should be stored at 20°C to 25°C (68°F to 77°F). The product is manufactured by Accord Healthcare Inc. in Raleigh, North Carolina, and is a product of India. There is information on lot number, expiry date, and dimensions provided.*

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25mg-21capsules (Lenalidomide 25mg Label)

This text provides information about Lenalidomide capsules, which contain 25 mg of Lenalidomide. It warns about the potential for human birth defects and advises storing the medication at temperatures between 20°C to 25°C. It also mentions the availability of a medication guide and instructs to refer to the prescribing information for dosing and administration details. The manufacturer is Accord Healthcare Inc. based in Raleigh, NC, with the product originating from India. The text includes a lot number and expiration date for identification purposes.*

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5mg-28capsules (Lenalidomide 5mg Label)

This text provides information about Lenalidomide capsules, each containing 5 mg of the active ingredient. It highlights the importance of storing the capsules at a temperature range of 20°C to 25°C. The text also mentions the risks of human birth defects and provides a precaution about the coding/serialization area on the packaging. It refers to a medication guide available and gives details on the recommended dosage. The manufacturing details are also provided, including the manufacturer, Accord Healthcare Inc., located in Raleigh, NC 27617, and that the product is from India.*

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Chemical Structure (Lenalidomide Capsules 01)

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Figure (Lenalidomide Capsules 02)

This is a table evaluating survival probabilities and progression-free survival for different treatments, including Rd Continuous, RA18, and MPT. It includes information on the survival probability, HR (@5%C), Logrank p-value, and the comparison of different treatments in terms of survival rates. The table also provides the number of subjects at risk for each treatment group.*

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Figure (Lenalidomide Capsules 03)

The text contains survival probability data comparing continuous Rd treatment with MPT and Ri18 regimens. The hazard ratios (HR) with 95% confidence intervals are provided for Rd Continuous vs MPT and Rd Continuous vs Ri18. A graph displaying overall survival in months is shown alongside the number of subjects at risk for each treatment group at different time points. The data suggests potential differences in survival outcomes between the treatment regimens.*

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Figure (Lenalidomide Capsules 04)

This is a comparative study between Lenalidomide and Placebo, with the hazard ratio (HR) of 0.38 showing a significant difference. The median progression-free survival (PFS) with Lenalidomide is 68.6 months compared to 22.5 months with Placebo. The number of subjects at risk and PFS events are also provided in the analysis.*

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Figure (Lenalidomide Capsules 05)

The text provides survival probability data of a lenalidomide study compared to a placebo. The hazard ratio (HR) with a 95% confidence interval is given as 0.53 (0.44, 0.64). The Kaplan-Meier median survival for lenalidomide is shown as 46.3 months (40.1, 56.6) compared to placebo with 23.8 months (21.0, 27.3). The text also mentions the percentage of progression-free survival events for lenalidomide (62%) and placebo (81%). Additionally, it provides information about the number of subjects at risk for each group.*

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Figure (Lenalidomide Capsules 06)

This text provides data on the proportion of subjects at different time points in a study comparing Lenalidomide/Dex vs. Placebo/Dex. The hazard ratio (HR) with 95% confidence interval is 0.285 (0.210-0.386), and a statistically significant difference was found with a Log Rank p-value of less than 0.001. Time to progression in months is indicated as 10 for Lenalidomide/Dex and 20 for Placebo/Dex, showing a difference in treatment outcomes.*

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Figure (Lenalidomide Capsules 07)

This text provides information about a study comparing Lenalidomide/Dex and Placebo/Dex treatments. The results show a significant difference in the time to progression between the two groups, with a hazard ratio (HR) of 0.324 and a 95% confidence interval of 0.240-0.438. The Log Rank p-value is less than 0.001, indicating a strong statistical significance. The graph displays the proportion of subjects over time in each treatment group, clearly demonstrating the difference in progression rates.*

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Figure (Lenalidomide Capsules 08)

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