FDA.reportPublic FDA data

Lenalidomide

Product NDC
60505-4534
11-digit product format
605054534
Labeler code
60505
Product ID
60505-4534_0ac7ca79-cd31-4bc1-ddc6-a90c9efcc1c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA211022
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, 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
60505-4534-1Lenalidomide100 in 1 BOTTLECAPSULE1006
60505-4534-2Lenalidomide28 in 1 BOTTLECAPSULE286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4534LENALIDOMIDE CAPSULE [APOTEX CORP.]5Current NDC, Legacy NDC, 2 package rows20240704_9943e098-20b0-dbb3-af12-7816eedd3f70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSN9943e098-20b0-dbb3-af12-7816eedd3f706
643712lenalidomide 15 MG Oral CapsulePSN9943e098-20b0-dbb3-af12-7816eedd3f706
1242231lenalidomide 2.5 MG Oral CapsulePSN9943e098-20b0-dbb3-af12-7816eedd3f706
1428947lenalidomide 20 MG Oral CapsulePSN9943e098-20b0-dbb3-af12-7816eedd3f706
643720lenalidomide 25 MG Oral CapsulePSN9943e098-20b0-dbb3-af12-7816eedd3f706
602912lenalidomide 5 MG Oral CapsulePSN9943e098-20b0-dbb3-af12-7816eedd3f706
602910lenalidomide 10 MG Oral CapsuleSCD9943e098-20b0-dbb3-af12-7816eedd3f706
643712lenalidomide 15 MG Oral CapsuleSCD9943e098-20b0-dbb3-af12-7816eedd3f706
1242231lenalidomide 2.5 MG Oral CapsuleSCD9943e098-20b0-dbb3-af12-7816eedd3f706
1428947lenalidomide 20 MG Oral CapsuleSCD9943e098-20b0-dbb3-af12-7816eedd3f706
643720lenalidomide 25 MG Oral CapsuleSCD9943e098-20b0-dbb3-af12-7816eedd3f706
602912lenalidomide 5 MG Oral CapsuleSCD9943e098-20b0-dbb3-af12-7816eedd3f706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-4534-160505453401100 CAPSULE in 1 BOTTLE (60505-4534-1) 100 capsule2022-09-060000-00-00NoNoCurrent
60505-4534-26050545340228 CAPSULE in 1 BOTTLE (60505-4534-2) 28 capsule2022-09-060000-00-00NoNoCurrent