Everolimus
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . for oral use Initial U.S. Approval: 2009
Approved
Approval ID
e3bca36b-29ed-4a2b-a1be-a57b6af805f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
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 Code0093-7769
Application NumberANDA210050
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateOctober 23, 2023
FDA Product Classification
INGREDIENTS (7)
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
EVEROLIMUSActive
Quantity: 10 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-7768
Application NumberANDA210050
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateOctober 23, 2023
FDA Product Classification
INGREDIENTS (7)
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
EVEROLIMUSActive
Quantity: 7.5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-7766
Application NumberANDA210050
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateOctober 23, 2023
FDA Product Classification
INGREDIENTS (7)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
EVEROLIMUSActive
Quantity: 2.5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-7767
Application NumberANDA210050
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateOctober 23, 2023
FDA Product Classification
INGREDIENTS (7)
EVEROLIMUSActive
Quantity: 5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT