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Armodafinil

These highlights do not include all the information needed to use Armodafinil Tablets safely and effectively. See full prescribing information for Armodafinil Tablets.Armodafinil Tablets, for oral use, C-IVInitial U.S. Approval: 2007

Approved
Approval ID

b3cac300-c3d2-4189-a410-2aaf3773c090

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 31, 2023

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.

Armodafinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0093-3092
Application NumberNDA021875
Product Classification
M
Marketing Category
C73605
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateMay 30, 2023
FDA Product Classification

INGREDIENTS (7)

ARMODAFINILActive
Quantity: 150 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Armodafinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0093-3090
Application NumberNDA021875
Product Classification
M
Marketing Category
C73605
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateMay 30, 2023
FDA Product Classification

INGREDIENTS (7)

ARMODAFINILActive
Quantity: 50 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT

Armodafinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0093-3094
Application NumberNDA021875
Product Classification
M
Marketing Category
C73605
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateMay 30, 2023
FDA Product Classification

INGREDIENTS (7)

ARMODAFINILActive
Quantity: 250 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Armodafinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0093-3093
Application NumberNDA021875
Product Classification
M
Marketing Category
C73605
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateMay 30, 2023
FDA Product Classification

INGREDIENTS (7)

ARMODAFINILActive
Quantity: 200 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

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Armodafinil - FDA Drug Approval Details