KISQALI
These highlights do not include all the information needed to use KISQALI safely and effectively. See full prescribing information for KISQALI. KISQALI (ribociclib) tablets, for oral use Initial U.S. Approval: 2017
Approved
Approval ID
aaeaef94-f3f5-4367-8ea2-b181d7be2da8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ribociclib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0867
Application NumberNDA209092
Product Classification
M
Marketing Category
C73594
G
Generic Name
ribociclib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2021
FDA Product Classification
INGREDIENTS (13)
RIBOCICLIB SUCCINATEActive
Quantity: 200 mg in 1 1
Code: BG7HLX2919
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ribociclib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0860
Application NumberNDA209092
Product Classification
M
Marketing Category
C73594
G
Generic Name
ribociclib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2021
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
RIBOCICLIB SUCCINATEActive
Quantity: 200 mg in 1 1
Code: BG7HLX2919
Classification: ACTIM
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ribociclib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0874
Application NumberNDA209092
Product Classification
M
Marketing Category
C73594
G
Generic Name
ribociclib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2021
FDA Product Classification
INGREDIENTS (13)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
RIBOCICLIB SUCCINATEActive
Quantity: 200 mg in 1 1
Code: BG7HLX2919
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT