LENALIDOMIDE

Product NDC
70710-1032
11-digit product format
707101032
Labeler code
70710
Product ID
70710-1032_d06dec99-06d1-4525-9caf-460747b53fbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LENALIDOMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA210154
Marketing category
ANDA
Marketing start
2022-09-12
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
70710-1032-1LENALIDOMIDE100 in 1 BOTTLECAPSULE1007
70710-1032-7LENALIDOMIDE28 in 1 BOTTLECAPSULE287

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1032LENALIDOMIDE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20240213_c98fb504-76d0-4c25-9c0b-412885828a7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSNc98fb504-76d0-4c25-9c0b-412885828a7a7
643712lenalidomide 15 MG Oral CapsulePSNc98fb504-76d0-4c25-9c0b-412885828a7a7
1242231lenalidomide 2.5 MG Oral CapsulePSNc98fb504-76d0-4c25-9c0b-412885828a7a7
1428947lenalidomide 20 MG Oral CapsulePSNc98fb504-76d0-4c25-9c0b-412885828a7a7
643720lenalidomide 25 MG Oral CapsulePSNc98fb504-76d0-4c25-9c0b-412885828a7a7
602912lenalidomide 5 MG Oral CapsulePSNc98fb504-76d0-4c25-9c0b-412885828a7a7
602910lenalidomide 10 MG Oral CapsuleSCDc98fb504-76d0-4c25-9c0b-412885828a7a7
643712lenalidomide 15 MG Oral CapsuleSCDc98fb504-76d0-4c25-9c0b-412885828a7a7
1242231lenalidomide 2.5 MG Oral CapsuleSCDc98fb504-76d0-4c25-9c0b-412885828a7a7
1428947lenalidomide 20 MG Oral CapsuleSCDc98fb504-76d0-4c25-9c0b-412885828a7a7
643720lenalidomide 25 MG Oral CapsuleSCDc98fb504-76d0-4c25-9c0b-412885828a7a7
602912lenalidomide 5 MG Oral CapsuleSCDc98fb504-76d0-4c25-9c0b-412885828a7a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1032-170710103201100 CAPSULE in 1 BOTTLE (70710-1032-1) 100 capsule2022-09-120000-00-00NoNoCurrent
70710-1032-77071010320728 CAPSULE in 1 BOTTLE (70710-1032-7) 28 capsule2022-09-120000-00-00NoNoCurrent