LENALIDOMIDE

Product NDC
31722-262
11-digit product format
317220262
Labeler code
31722
Product ID
31722-262_1f172b43-d7bb-0805-e063-6394a90ab37d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LENALIDOMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA212414
Marketing category
ANDA
Marketing start
2023-05-11
Substance
LENALIDOMIDE
Active strength
25 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
LENALIDOMIDE25 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
31722-262-01LENALIDOMIDE100 in 1 BOTTLECAPSULE1003
31722-262-21LENALIDOMIDE21 in 1 BOTTLECAPSULE213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-262-21EA - Each31722-26245b408e9-5908-4e45-9b5b-0b70ffec3cc912023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-262LENALIDOMIDE (LENALIDOMIDE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]3Current NDC, 2 package rows20240808_f27092f3-3977-4f4a-b214-45309e136e46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
643712lenalidomide 15 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
1242231lenalidomide 2.5 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
1428947lenalidomide 20 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
643720lenalidomide 25 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
602912lenalidomide 5 MG Oral CapsulePSNf27092f3-3977-4f4a-b214-45309e136e463
602910lenalidomide 10 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463
643712lenalidomide 15 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463
1242231lenalidomide 2.5 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463
1428947lenalidomide 20 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463
643720lenalidomide 25 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463
602912lenalidomide 5 MG Oral CapsuleSCDf27092f3-3977-4f4a-b214-45309e136e463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-262-0131722026201100 CAPSULE in 1 BOTTLE (31722-262-01) 100 capsule2023-05-11NoNoCurrent
31722-262-213172202622121 CAPSULE in 1 BOTTLE (31722-262-21) 21 capsule2023-05-11NoNoCurrent