Ibrance
These highlights do not include all the information needed to use IBRANCE safely and effectively. See full prescribing information for IBRANCE. IBRANCE (palbociclib) tablets, for oral use Initial U.S. Approval: 2015
Approved
Approval ID
89a142d5-7e61-48bf-9e77-e2cd124c4792
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 4, 2024
Manufacturers
FDA
U.S. Pharmaceuticals
DUNS: 829076905
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
palbociclib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-284
Application NumberNDA212436
Product Classification
M
Marketing Category
C73594
G
Generic Name
palbociclib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2019
FDA Product Classification
INGREDIENTS (11)
PALBOCICLIBActive
Quantity: 75 mg in 1 1
Code: G9ZF61LE7G
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
palbociclib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-486
Application NumberNDA212436
Product Classification
M
Marketing Category
C73594
G
Generic Name
palbociclib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2019
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PALBOCICLIBActive
Quantity: 100 mg in 1 1
Code: G9ZF61LE7G
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
palbociclib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-688
Application NumberNDA212436
Product Classification
M
Marketing Category
C73594
G
Generic Name
palbociclib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 15, 2019
FDA Product Classification
INGREDIENTS (11)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PALBOCICLIBActive
Quantity: 125 mg in 1 1
Code: G9ZF61LE7G
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT