Lenalidomide

Product NDC
0480-1244
11-digit product format
004801244
Labeler code
0480
Product ID
0480-1244_f264d32e-0ed0-49b6-80f7-8009ee4803ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA201452
Marketing category
ANDA
Marketing start
2022-03-03
Substance
LENALIDOMIDE
Active strength
15 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
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
0480-1244-21Lenalidomide21 in 1 BOTTLECAPSULE215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-1244LENALIDOMIDE CAPSULE [TEVA PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20220626_1b2716cf-24b4-4157-a218-58ede63917bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSN1b2716cf-24b4-4157-a218-58ede63917bd5
643712lenalidomide 15 MG Oral CapsulePSN1b2716cf-24b4-4157-a218-58ede63917bd5
1242231lenalidomide 2.5 MG Oral CapsulePSN1b2716cf-24b4-4157-a218-58ede63917bd5
1428947lenalidomide 20 MG Oral CapsulePSN1b2716cf-24b4-4157-a218-58ede63917bd5
643720lenalidomide 25 MG Oral CapsulePSN1b2716cf-24b4-4157-a218-58ede63917bd5
602912lenalidomide 5 MG Oral CapsulePSN1b2716cf-24b4-4157-a218-58ede63917bd5
602910lenalidomide 10 MG Oral CapsuleSCD1b2716cf-24b4-4157-a218-58ede63917bd5
643712lenalidomide 15 MG Oral CapsuleSCD1b2716cf-24b4-4157-a218-58ede63917bd5
1242231lenalidomide 2.5 MG Oral CapsuleSCD1b2716cf-24b4-4157-a218-58ede63917bd5
1428947lenalidomide 20 MG Oral CapsuleSCD1b2716cf-24b4-4157-a218-58ede63917bd5
643720lenalidomide 25 MG Oral CapsuleSCD1b2716cf-24b4-4157-a218-58ede63917bd5
602912lenalidomide 5 MG Oral CapsuleSCD1b2716cf-24b4-4157-a218-58ede63917bd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0480-1244-210048012442121 CAPSULE in 1 BOTTLE (0480-1244-21) 21 capsule2022-03-030000-00-00NoNoCurrent