Xalkori
These highlights do not include all the information needed to use XALKORI safely and effectively. See full prescribing information for XALKORI. XALKORI (crizotinib) capsules, for oral useXALKORI (crizotinib) oral pelletsInitial U.S. Approval: 2011
Approved
Approval ID
2a51b0de-47d6-455e-a94c-d2c737b04ff7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CRIZOTINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0251
Application NumberNDA217581
Product Classification
M
Marketing Category
C73594
G
Generic Name
CRIZOTINIB
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (12)
CRIZOTINIBActive
Quantity: 20 mg in 1 1
Code: 53AH36668S
Classification: ACTIB
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CRIZOTINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0507
Application NumberNDA217581
Product Classification
M
Marketing Category
C73594
G
Generic Name
CRIZOTINIB
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (12)
CRIZOTINIBActive
Quantity: 50 mg in 1 1
Code: 53AH36668S
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
CRIZOTINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-1500
Application NumberNDA217581
Product Classification
M
Marketing Category
C73594
G
Generic Name
CRIZOTINIB
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (12)
CRIZOTINIBActive
Quantity: 150 mg in 1 1
Code: 53AH36668S
Classification: ACTIB
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
CRIZOTINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-8141
Application NumberNDA202570
Product Classification
M
Marketing Category
C73594
G
Generic Name
CRIZOTINIB
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (14)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CRIZOTINIBActive
Quantity: 200 mg in 1 1
Code: 53AH36668S
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
CRIZOTINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-8140
Application NumberNDA202570
Product Classification
M
Marketing Category
C73594
G
Generic Name
CRIZOTINIB
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (14)
CRIZOTINIBActive
Quantity: 250 mg in 1 1
Code: 53AH36668S
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT