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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

2693c497-a70b-4d00-b6db-602c872e5bed

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 8, 2022

Manufacturers
FDA

Ascend Laboratories, LLC

DUNS: 141250469

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 Code67877-718
Application NumberANDA214138
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2021
FDA Product Classification

INGREDIENTS (7)

BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
EVEROLIMUSActive
Quantity: 0.25 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT

Everolimus

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67877-720
Application NumberANDA214138
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2021
FDA Product Classification

INGREDIENTS (7)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
EVEROLIMUSActive
Quantity: 0.75 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Everolimus

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67877-721
Application NumberANDA214138
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2021
FDA Product Classification

INGREDIENTS (7)

EVEROLIMUSActive
Quantity: 1 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

Everolimus

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67877-719
Application NumberANDA214138
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2021
FDA Product Classification

INGREDIENTS (7)

EVEROLIMUSActive
Quantity: 0.50 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Everolimus - FDA Drug Approval Details