Everolimus
These highlights do not include all the information needed to use EVEROLIMUS tablets safely and effectively. See full prescribing information for EVEROLIMUS tablets. EVEROLIMUS tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
d44998bb-5deb-4ee7-a0a5-979fe3f49557
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 8, 2023
Manufacturers
FDA
Natco Pharma Limited
DUNS: 650224736
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63850-0063
Application NumberANDA205432
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2023
FDA Product Classification
INGREDIENTS (6)
EVEROLIMUSActive
Quantity: 0.5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63850-0062
Application NumberANDA205432
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2023
FDA Product Classification
INGREDIENTS (6)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
EVEROLIMUSActive
Quantity: 0.25 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63850-0064
Application NumberANDA205432
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2023
FDA Product Classification
INGREDIENTS (6)
EVEROLIMUSActive
Quantity: 0.75 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT