LENALIDOMIDE

Product NDC
60219-1717
11-digit product format
602191717
Labeler code
60219
Product ID
60219-1717_85e664d1-1d56-4b9b-b2a1-96b32b5b1a7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA216213
Marketing category
ANDA
Marketing start
2025-02-12
Substance
LENALIDOMIDE
Active strength
15 mg/1
Pharmacologic classes
Thalidomide Analog [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LENALIDOMIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LENALIDOMIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF0P408N6V4
Rxcui602910, 602912, 643712, 643720, 1242231, 1428947

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba3b6b9d-cf27-aec0-3395-500a538c6915Product name620260306

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1717-1LENALIDOMIDE21 in 1 BOTTLECAPSULE216
60219-1717-2LENALIDOMIDE100 in 1 BOTTLECAPSULE1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1717LENALIDOMIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]5Current NDC, 2 package rows20250214_da7b5dda-79ed-4c4a-88aa-52394fdc7c54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
643712lenalidomide 15 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
1242231lenalidomide 2.5 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
1428947lenalidomide 20 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
643720lenalidomide 25 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
602912lenalidomide 5 MG Oral CapsulePSNda7b5dda-79ed-4c4a-88aa-52394fdc7c546
602910lenalidomide 10 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546
643712lenalidomide 15 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546
1242231lenalidomide 2.5 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546
1428947lenalidomide 20 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546
643720lenalidomide 25 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546
602912lenalidomide 5 MG Oral CapsuleSCDda7b5dda-79ed-4c4a-88aa-52394fdc7c546

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60219-1717-16021917170121 CAPSULE in 1 BOTTLE (60219-1717-1) 21 capsule2025-02-12NoNoCurrent
60219-1717-260219171702100 CAPSULE in 1 BOTTLE (60219-1717-2) 100 capsule2025-02-12NoNoCurrent