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
b7c7c9a4-994f-43dc-8cd6-cd6eeed6fa89
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2023
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 4
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 Code0378-3096
Application NumberANDA212936
Product Classification
M
Marketing Category
C73584
G
Generic Name
everolimus
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2023
FDA Product Classification
INGREDIENTS (7)
EVEROLIMUSActive
Quantity: 2.5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-3098
Application NumberANDA212936
Product Classification
M
Marketing Category
C73584
G
Generic Name
everolimus
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2023
FDA Product Classification
INGREDIENTS (7)
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
EVEROLIMUSActive
Quantity: 7.5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-3097
Application NumberANDA212936
Product Classification
M
Marketing Category
C73584
G
Generic Name
everolimus
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2023
FDA Product Classification
INGREDIENTS (7)
EVEROLIMUSActive
Quantity: 5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-3099
Application NumberANDA212936
Product Classification
M
Marketing Category
C73584
G
Generic Name
everolimus
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2023
FDA Product Classification
INGREDIENTS (10)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
EVEROLIMUSActive
Quantity: 10 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT