Lenalidomide

Product NDC
70377-051
11-digit product format
703770051
Labeler code
70377
Product ID
70377-051_709e3342-23d5-10cd-3241-5ef6fdf924fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
BIOCON PHARMA INC.,
Application
ANDA215759
Marketing category
ANDA
Marketing start
2025-03-03
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
70377-051-12Lenalidomide100 in 1 BOTTLECAPSULE1009
70377-051-13Lenalidomide28 in 1 BOTTLECAPSULE289

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70377-051-13EA - Each70377-05126bd2d2b-d23b-4fd6-9ca2-5032fc280ae512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70377-051LENALIDOMIDE CAPSULE [BIOCON PHARMA INC.,]9Current NDC, 2 package rows20250306_ed7a3099-ce31-4865-b212-358d9ff6261b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
643712lenalidomide 15 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
1242231lenalidomide 2.5 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
1428947lenalidomide 20 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
643720lenalidomide 25 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
602912lenalidomide 5 MG Oral CapsulePSNed7a3099-ce31-4865-b212-358d9ff6261b9
602910lenalidomide 10 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9
643712lenalidomide 15 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9
1242231lenalidomide 2.5 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9
1428947lenalidomide 20 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9
643720lenalidomide 25 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9
602912lenalidomide 5 MG Oral CapsuleSCDed7a3099-ce31-4865-b212-358d9ff6261b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70377-051-1270377005112100 CAPSULE in 1 BOTTLE (70377-051-12) 100 capsule2025-03-03NoNoHistorical
70377-051-137037700511328 CAPSULE in 1 BOTTLE (70377-051-13) 28 capsule2025-03-03NoNoHistorical