lenalidomide

Product NDC
69097-382
11-digit product format
690970382
Labeler code
69097
Product ID
69097-382_6b77715c-f6f7-408c-8efd-bfdd3125aec4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lenalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA210435
Marketing category
ANDA
Marketing start
2022-09-06
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, 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
69097-382-73lenalidomide28 in 1 BOTTLE, PLASTICCAPSULE286

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-382-73EA - Each69097-382c59ac3f7-4104-4796-a6f5-e49abaafb00d12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-382LENALIDOMIDE CAPSULE [CIPLA USA INC.]6Current NDC, Legacy NDC, 1 package rows20250104_ba2a07fd-ca60-40bc-b79b-9caf81900fa3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602910lenalidomide 10 MG Oral CapsulePSNba2a07fd-ca60-40bc-b79b-9caf81900fa36
643712lenalidomide 15 MG Oral CapsulePSNba2a07fd-ca60-40bc-b79b-9caf81900fa36
1428947lenalidomide 20 MG Oral CapsulePSNba2a07fd-ca60-40bc-b79b-9caf81900fa36
643720lenalidomide 25 MG Oral CapsulePSNba2a07fd-ca60-40bc-b79b-9caf81900fa36
602912lenalidomide 5 MG Oral CapsulePSNba2a07fd-ca60-40bc-b79b-9caf81900fa36
602910lenalidomide 10 MG Oral CapsuleSCDba2a07fd-ca60-40bc-b79b-9caf81900fa36
643712lenalidomide 15 MG Oral CapsuleSCDba2a07fd-ca60-40bc-b79b-9caf81900fa36
1428947lenalidomide 20 MG Oral CapsuleSCDba2a07fd-ca60-40bc-b79b-9caf81900fa36
643720lenalidomide 25 MG Oral CapsuleSCDba2a07fd-ca60-40bc-b79b-9caf81900fa36
602912lenalidomide 5 MG Oral CapsuleSCDba2a07fd-ca60-40bc-b79b-9caf81900fa36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-382-736909703827328 CAPSULE in 1 BOTTLE, PLASTIC (69097-382-73) 28 capsule2022-09-060000-00-00NoNoCurrent