Lenalidomide

Product NDC
16729-697
11-digit product format
167290697
Labeler code
16729
Product ID
16729-697_513e8d33-e9bf-df2b-e063-6394a90a1ee9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA218872
Marketing category
ANDA
Marketing start
2026-04-08
Substance
LENALIDOMIDE
Active strength
25 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
LENALIDOMIDE25 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
16729-697-06Lenalidomide21 in 1 BOTTLECAPSULE216

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
643712lenalidomide 15 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
1242231lenalidomide 2.5 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
1428947lenalidomide 20 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
643720lenalidomide 25 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
602912lenalidomide 5 MG Oral CapsulePSN9c414531-a3bf-455a-aca7-9e716f42099a6
602910lenalidomide 10 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6
643712lenalidomide 15 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6
1242231lenalidomide 2.5 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6
1428947lenalidomide 20 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6
643720lenalidomide 25 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6
602912lenalidomide 5 MG Oral CapsuleSCD9c414531-a3bf-455a-aca7-9e716f42099a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16729-697-061672906970621 CAPSULE in 1 BOTTLE (16729-697-06) 21 capsule2026-04-08NoNoCurrent