FDA.reportPublic FDA data

Verzenio

Product NDC
0002-4483
11-digit product format
000024483
Labeler code
0002
Product ID
0002-4483_01706851-8b56-40b8-9e22-e454b3e24f95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
abemaciclib
Dosage form
TABLET
Route
ORAL
Labeler
Eli Lilly and Company
Application
NDA208716
Marketing category
NDA
Marketing start
2017-09-28
Substance
ABEMACICLIB
Active strength
50 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Verzenio
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ABEMACICLIB50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii60UAB198HK
Rxcui1946830, 1946836, 1946838, 1946840, 1946842, 1946844, 1946846, 1946848

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
54b69052-dc0f-43b6-aed1-9c546fcb601cProduct name120171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-4483-54Verzenio1 in 1 CARTONTABLET127
0002-4483-54Verzenio14 in 1 BLISTER PACKTABLET1427
0002-4483-62Verzenio14 in 1 BLISTER PACKTABLET1427
0002-4483-62Verzenio2 in 1 CARTONTABLET227

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-4483-54EA - Each0002-448326f85b60-ad96-407d-9943-c4aeff79e62512017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-4483VERZENIO (ABEMACICLIB) TABLET [ELI LILLY AND COMPANY]26Current NDC, Legacy NDC, 4 package rows20250309_be4bc0de-0fdc-4d46-8d25-be43c79e6a06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1946838abemaciclib 100 MG Oral TabletPSNbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946842abemaciclib 150 MG Oral TabletPSNbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946846abemaciclib 200 MG Oral TabletPSNbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946830abemaciclib 50 MG Oral TabletPSNbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946840Verzenio 100 MG Oral TabletPSNbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946844Verzenio 150 MG Oral TabletPSNbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946848Verzenio 200 MG Oral TabletPSNbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946836Verzenio 50 MG Oral TabletPSNbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946840abemaciclib 100 MG Oral Tablet [Verzenio]SBDbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946844abemaciclib 150 MG Oral Tablet [Verzenio]SBDbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946848abemaciclib 200 MG Oral Tablet [Verzenio]SBDbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946836abemaciclib 50 MG Oral Tablet [Verzenio]SBDbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946838abemaciclib 100 MG Oral TabletSCDbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946842abemaciclib 150 MG Oral TabletSCDbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946846abemaciclib 200 MG Oral TabletSCDbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946830abemaciclib 50 MG Oral TabletSCDbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946840Verzenio 100 MG Oral TabletSYbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946844Verzenio 150 MG Oral TabletSYbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946848Verzenio 200 MG Oral TabletSYbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627
1946836Verzenio 50 MG Oral TabletSYbe4bc0de-0fdc-4d46-8d25-be43c79e6a0627

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-4483-54000024483541 BLISTER PACK in 1 CARTON (0002-4483-54) / 14 TABLET in 1 BLISTER PACK1 blister pack2017-10-060000-00-00NoNoCurrent
0002-4483-62000024483622 BLISTER PACK in 1 CARTON (0002-4483-62) / 14 TABLET in 1 BLISTER PACK2 blister pack2025-02-15YesNoHistorical