Lenalidomide

Product NDC
69097-604
11-digit product format
690970604
Labeler code
69097
Product ID
69097-604_8eeb4be1-20a8-4250-b002-ec6705fb1e18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA214618
Marketing category
ANDA
Marketing start
2023-03-09
Substance
LENALIDOMIDE
Active strength
2.5 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
LENALIDOMIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF0P408N6V4
Rxcui1242231

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
69097-604-73Lenalidomide28 in 1 BOTTLECAPSULE281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-604LENALIDOMIDE CAPSULE [CIPLA USA INC.]1Current NDC, 1 package rows20230310_96df285d-dd13-4083-b2c6-e5c799e7587b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1242231lenalidomide 2.5 MG Oral CapsulePSN96df285d-dd13-4083-b2c6-e5c799e7587b1
1242231lenalidomide 2.5 MG Oral CapsuleSCD96df285d-dd13-4083-b2c6-e5c799e7587b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-604-736909706047328 CAPSULE in 1 BOTTLE (69097-604-73) 28 capsule2023-03-09NoNoCurrent