Verzenio
These highlights do not include all the information needed to use VERZENIO safely and effectively. See full prescribing information for VERZENIO. VERZENIO (abemaciclib) tablets, for oral useInitial U.S. Approval: 2017
Approved
Approval ID
be4bc0de-0fdc-4d46-8d25-be43c79e6a06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
abemaciclib
PRODUCT DETAILS
NDC Product Code0002-4815
Application NumberNDA208716
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 28, 2020
Generic Nameabemaciclib
INGREDIENTS (11)
abemaciclibActive
Quantity: 100 mg in 1 1
Code: 60UAB198HK
Classification: ACTIB
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
abemaciclib
PRODUCT DETAILS
NDC Product Code0002-5337
Application NumberNDA208716
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 28, 2020
Generic Nameabemaciclib
INGREDIENTS (12)
abemaciclibActive
Quantity: 150 mg in 1 1
Code: 60UAB198HK
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
abemaciclib
PRODUCT DETAILS
NDC Product Code0002-4483
Application NumberNDA208716
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 28, 2020
Generic Nameabemaciclib
INGREDIENTS (13)
abemaciclibActive
Quantity: 50 mg in 1 1
Code: 60UAB198HK
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
abemaciclib
PRODUCT DETAILS
NDC Product Code0002-6216
Application NumberNDA208716
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 28, 2020
Generic Nameabemaciclib
INGREDIENTS (13)
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
abemaciclibActive
Quantity: 200 mg in 1 1
Code: 60UAB198HK
Classification: ACTIB
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT