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
5fb55800-f322-6bb6-9dde-622925ef28bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 2, 2023
Manufacturers
FDA
Biocon Pharma Inc.
DUNS: 080000063
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 Code70377-012
Application NumberANDA214182
Product Classification
M
Marketing Category
C73584
G
Generic Name
everolimus
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2023
FDA Product Classification
INGREDIENTS (7)
EverolimusActive
Quantity: 7.5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
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 Code70377-010
Application NumberANDA214182
Product Classification
M
Marketing Category
C73584
G
Generic Name
everolimus
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2023
FDA Product Classification
INGREDIENTS (7)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
EverolimusActive
Quantity: 2.5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70377-013
Application NumberANDA214182
Product Classification
M
Marketing Category
C73584
G
Generic Name
everolimus
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2023
FDA Product Classification
INGREDIENTS (7)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
EverolimusActive
Quantity: 10 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
everolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70377-011
Application NumberANDA214182
Product Classification
M
Marketing Category
C73584
G
Generic Name
everolimus
Product Specifications
Route of AdministrationORAL
Effective DateJune 2, 2023
FDA Product Classification
INGREDIENTS (7)
EverolimusActive
Quantity: 5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT