Nuvigil
These highlights do not include all the information needed to use NUVIGIL safely and effectively. See full prescribing information for NUVIGIL. Initial U.S. Approval: 2007
Approved
Approval ID
d878aed0-ddbf-8fa1-abf7-d3e480260845
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2022
Manufacturers
FDA
Cephalon, LLC
DUNS: 183236314
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 Code63459-205
Application NumberNDA021875
Product Classification
M
Marketing Category
C73594
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2023
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ARMODAFINILActive
Quantity: 50 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
Armodafinil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63459-215
Application NumberNDA021875
Product Classification
M
Marketing Category
C73594
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2023
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ARMODAFINILActive
Quantity: 150 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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 Code63459-225
Application NumberNDA021875
Product Classification
M
Marketing Category
C73594
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2023
FDA Product Classification
INGREDIENTS (7)
ARMODAFINILActive
Quantity: 250 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Armodafinil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63459-220
Application NumberNDA021875
Product Classification
M
Marketing Category
C73594
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2023
FDA Product Classification
INGREDIENTS (7)
ARMODAFINILActive
Quantity: 200 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT