Lenalidomide Capsule
Product Images NDC 0378-1941

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Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Lenalidomide (NDC 0378-1941). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Pharmaceuticals 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

Lenalidomide Capsules 5 mg Bottle Label (Image 02)

Lenalidomide Capsules 5 mg Bottle Label (Image 02)
Each capsule contains Lenalidomide 5 mg and should be used according to the prescribing information for dosage and administration. The medicine should be kept out of the reach of children and stored at a temperature of 20° to 25°C. The medication is manufactured by Mylan Pharmaceuticals Inc in India and should be stored in a tight, light-resistant container with child-resistant closure. The medicine can cause human birth defects so a pharmacist should dispense it along with a Medication Guide for each patient. Variable data coding such as LOT and EXP should also be printed wherever applicable. NDC 0378-1936-28 is the product code for Lenalidomide Capsules with 28 capsules in each pack.*
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Lenalidomide Capsules 10 mg Bottle Label (Image 03)

Lenalidomide Capsules 10 mg Bottle Label (Image 03)
Each capsule contains 10mg of Lenalidomide. This medicine comes with prescription information for dosing and administration. It is important to keep the capsules out of reach of children and to store them at a temperature between 20°C and 25°C. The medication may cause potential birth defects. The medicine is manufactured by Mylan Pharmaceuticals in India and comes in a bottle of 28 capsules. The NDC code for the product is 0378-1937-28. The medicine should be dispensed in a tight and light-resistant container with a child-resistant closure. The LOT and EXP information should be printed with the variable data coding.*
FDA Label Image

Lenalidomide Capsules 15 mg Bottle Label (Image 04)

Lenalidomide Capsules 15 mg Bottle Label (Image 04)
This is a medication in capsule form containing Lenalidomide and is typically taken as prescribed by a doctor. The medication should be kept out of reach of children in a closed container at room temperature as directed by the USP. The medication is manufactured by Mylan Pharmaceuticals and is made in India. The National Drug Code for this medication is 0378-1941-21. The medication should be dispensed in a light-resistant container that is child-resistant. The accompanying medication guide should be given to each patient. The Lot and Exp of the medication will be printed along with variable data online coding where applicable.*
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Lenalidomide Capsules 25 mg Bottle Label (Image 06)

FDA Label Image

Lenalidomide Structural Formula (Image 07)

Lenalidomide Structural Formula (Image 07)
This appears to be the chemical name or formula for a compound: 3-(4-Amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione, commonly known as NH. It is not possible to provide any further useful information without additional context about the compound or its purpose.*
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Kaplan-meier Curves Of Progression-free Survival Based On Irac Assessment (itt Mm Population) Between Arms Rd Continuous, Rd18 And Mpt Cutoff Date: 24 May 2013 (Image 08)

Kaplan-meier Curves Of Progression-free Survival Based On Irac Assessment (itt Mm Population) Between Arms Rd Continuous, Rd18 And Mpt Cutoff Date: 24 May 2013 (Image 08)
This appears to be a table or chart showing data related to survival probability, progression-free survival, and number of subjects in a study involving treatments of dexamethasone, melphalan, prednisone, thalidomide, and lenalidomide capsules. The table includes percentages, confidence intervals, hazard ratios, and other statistical information, but a specific interpretation or conclusion cannot be made without additional context.*
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Kaplan-meier Curves Of Overall Survival (itt Mm Population) Between Arms Rd Continuous, Rd18 And Mpt Cutoff Date: 03 Mar 2014 (Image 09)

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Kaplan-meier Estimate Of Time To Progression — Mm Study 1 (Image 10)

Kaplan-meier Estimate Of Time To Progression — Mm Study 1 (Image 10)
This is a statistical analysis of a clinical trial comparing the treatment with Lenalidomide and Dex (254 participants) to placebo and Dex (50 participants) for Time to Progression in months. The results show a significant difference between the two treatments with a HR (Hazard Ratio) of 0.285 (95% confidence interval: 0.210-0.386) and a p-value < 0.001.*
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Kaplan-meier Estimate Of Time To Progression — Mm Study 2 (Image 11)

Kaplan-meier Estimate Of Time To Progression — Mm Study 2 (Image 11)
The text represents a graph or a chart displaying the proportion of subjects and the time to progression in months. It includes data on HR (95% Cl) and Log Rank p values for two treatments: Lenalidomide/Dex and Placebo/Dex. The chart shows that the Lenalidomide/Dex treatment had a significantly higher proportion of subjects with a lower time to progression compared to the placebo/Dex treatment.*
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Kaplan-meier Curves Of Progression-free Survival From Randomization (itt Post-auto-hsct Population) In Mm Maintenance Study 1 Between Lenalidomide Capsules And Placebo Arms (updated Cutoff Date 1 March 2015) (Image 12)

FDA Label Image

Kaplan-meier Curves Of Progression-free Survival From Randomization (itt Post-auto-hsct Population) In Mm Maintenance Study 2 Between Lenalidomide Capsules And Placebo Arms (updated Cutoff Date 1 March 2015) (Image 13)

Kaplan-meier Curves Of Progression-free Survival From Randomization (itt Post-auto-hsct Population) In Mm Maintenance Study 2 Between Lenalidomide Capsules And Placebo Arms (updated Cutoff Date 1 March 2015) (Image 13)
The text describes survival probability and compares the efficacy of Lenalidomide versus placebo in terms of HR, median survival, and progression-free survival. It also shows the number of subjects who experienced PFS events with each treatment.*
FDA Label Image

Kaplan-meier Curves Of Progression-free Survival By Irc Assessment Between Arms In Augment Trial (itt Fl And Mzl Population) (Image 14)

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