Everolimus
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2009
Approved
Approval ID
ca1a987e-f763-4026-93c5-c545ca95826c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2023
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
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 Code0378-0005
Application NumberANDA210130
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2022
FDA Product Classification
INGREDIENTS (11)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
EVEROLIMUSActive
Quantity: 2 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0006
Application NumberANDA210130
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2022
FDA Product Classification
INGREDIENTS (11)
EVEROLIMUSActive
Quantity: 3 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
Everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-0007
Application NumberANDA210130
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateMarch 10, 2022
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
EVEROLIMUSActive
Quantity: 5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT