PEMAZYRE
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . PEMAZYRE® (pemigatinib) tablets, for oral use Initial U.S. Approval: 2020
Approved
Approval ID
9e1f2222-1d89-4e63-989c-ccebe2ab1eb4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2023
Manufacturers
FDA
Incyte Corporation
DUNS: 556967347
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pemigatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50881-028
Application NumberNDA213736
Product Classification
M
Marketing Category
C73594
G
Generic Name
pemigatinib
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (4)
PEMIGATINIBActive
Quantity: 13.5 mg in 1 1
Code: Y6BX7BL23K
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
pemigatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50881-026
Application NumberNDA213736
Product Classification
M
Marketing Category
C73594
G
Generic Name
pemigatinib
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (4)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PEMIGATINIBActive
Quantity: 4.5 mg in 1 1
Code: Y6BX7BL23K
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
pemigatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50881-027
Application NumberNDA213736
Product Classification
M
Marketing Category
C73594
G
Generic Name
pemigatinib
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (4)
PEMIGATINIBActive
Quantity: 9 mg in 1 1
Code: Y6BX7BL23K
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT