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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 useInitial U.S. Approval: 2009

Approved
Approval ID

5aaf2fb7-93f6-40d6-941a-9583a3794ce7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 13, 2022

Manufacturers
FDA

Hikma Pharmaceuticals USA Inc.

DUNS: 080189610

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 Code0054-0497
Application NumberANDA207486
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2022
FDA Product Classification

INGREDIENTS (6)

EVEROLIMUSActive
Quantity: 7.5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Everolimus

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0054-0481
Application NumberANDA207486
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2022
FDA Product Classification

INGREDIENTS (6)

BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
EVEROLIMUSActive
Quantity: 5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Everolimus

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0054-0480
Application NumberANDA207486
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2022
FDA Product Classification

INGREDIENTS (6)

EVEROLIMUSActive
Quantity: 2.5 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT

Everolimus

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0054-0482
Application NumberANDA207486
Product Classification
M
Marketing Category
C73584
G
Generic Name
Everolimus
Product Specifications
Route of AdministrationORAL
Effective DateMay 13, 2022
FDA Product Classification

INGREDIENTS (6)

EVEROLIMUSActive
Quantity: 10 mg in 1 1
Code: 9HW64Q8G6G
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Everolimus - FDA Drug Approval Details