FDA.reportPublic FDA data

LENALIDOMIDE

Product NDC
0574-1415
11-digit product format
005741415
Labeler code
0574
Product ID
0574-1415_dffe719b-4f61-47e2-b71c-673322d487f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Padagis US LLC
Application
ANDA217265
Marketing category
ANDA
Marketing start
2026-01-31
Substance
LENALIDOMIDE
Active strength
15 mg/1
Pharmacologic classes
Thalidomide Analog [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LENALIDOMIDE
Listing expiration
2026-12-31

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
0574-1415-21LENALIDOMIDE21 in 1 BOTTLECAPSULE211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-1415-21EA - Each0574-1415f586c26a-5501-40cb-9a2e-c687308111cc12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
643712lenalidomide 15 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
1242231lenalidomide 2.5 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
1428947lenalidomide 20 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
643720lenalidomide 25 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
602912lenalidomide 5 MG Oral CapsulePSNdffe719b-4f61-47e2-b71c-673322d487f51
602910lenalidomide 10 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51
643712lenalidomide 15 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51
1242231lenalidomide 2.5 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51
1428947lenalidomide 20 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51
643720lenalidomide 25 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51
602912lenalidomide 5 MG Oral CapsuleSCDdffe719b-4f61-47e2-b71c-673322d487f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0574-1415-210057414152121 CAPSULE in 1 BOTTLE (0574-1415-21) 21 capsule2026-01-31NoNoHistorical