lenalidomide

Product NDC
76282-698
11-digit product format
762820698
Labeler code
76282
Product ID
76282-698_e6e7ab13-5475-4755-8e1a-f643425297b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
EXELAN PHARMACEUTICALS INC.
Application
ANDA210435
Marketing category
ANDA
Marketing start
2022-09-06
Substance
LENALIDOMIDE
Active strength
10 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
LENALIDOMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF0P408N6V4
Rxcui602910, 602912, 643712, 643720, 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
76282-698-48lenalidomide28 in 1 BOTTLE, PLASTICCAPSULE286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-698-48EA - Each76282-698c53ce859-09a3-4e49-a823-43f16466b7c812024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-698LENALIDOMIDE CAPSULE [EXELAN PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 1 package rows20240622_682e8a86-9f49-45db-a2ea-403ee1dc62d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSN682e8a86-9f49-45db-a2ea-403ee1dc62d26
643712lenalidomide 15 MG Oral CapsulePSN682e8a86-9f49-45db-a2ea-403ee1dc62d26
1428947lenalidomide 20 MG Oral CapsulePSN682e8a86-9f49-45db-a2ea-403ee1dc62d26
643720lenalidomide 25 MG Oral CapsulePSN682e8a86-9f49-45db-a2ea-403ee1dc62d26
602912lenalidomide 5 MG Oral CapsulePSN682e8a86-9f49-45db-a2ea-403ee1dc62d26
602910lenalidomide 10 MG Oral CapsuleSCD682e8a86-9f49-45db-a2ea-403ee1dc62d26
643712lenalidomide 15 MG Oral CapsuleSCD682e8a86-9f49-45db-a2ea-403ee1dc62d26
1428947lenalidomide 20 MG Oral CapsuleSCD682e8a86-9f49-45db-a2ea-403ee1dc62d26
643720lenalidomide 25 MG Oral CapsuleSCD682e8a86-9f49-45db-a2ea-403ee1dc62d26
602912lenalidomide 5 MG Oral CapsuleSCD682e8a86-9f49-45db-a2ea-403ee1dc62d26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-698-487628206984828 CAPSULE in 1 BOTTLE, PLASTIC (76282-698-48) 28 capsule2022-09-060000-00-00NoNoCurrent