Vizimpro
These highlights do not include all the information needed to use VIZIMPRO safely and effectively. See full prescribing information for VIZIMPRO. VIZIMPRO (dacomitinib) tablets, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
4ab27d2f-e385-4e9c-b324-fa69c10b855a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dacomitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-0197
Application NumberNDA211288
Product Classification
M
Marketing Category
C73594
G
Generic Name
dacomitinib
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2020
FDA Product Classification
INGREDIENTS (10)
DACOMITINIBActive
Quantity: 15 mg in 1 1
Code: 5092U85G58
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
dacomitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-1198
Application NumberNDA211288
Product Classification
M
Marketing Category
C73594
G
Generic Name
dacomitinib
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2020
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
DACOMITINIBActive
Quantity: 30 mg in 1 1
Code: 5092U85G58
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
dacomitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-2299
Application NumberNDA211288
Product Classification
M
Marketing Category
C73594
G
Generic Name
dacomitinib
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2020
FDA Product Classification
INGREDIENTS (10)
DACOMITINIBActive
Quantity: 45 mg in 1 1
Code: 5092U85G58
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT