Modafinil
These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIVInitial U.S. Approval: 1998
Approved
Approval ID
15739a31-2433-49b5-90ea-b974214f73be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
Viona Pharmaceuticals Inc
DUNS: 081468959
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Modafinil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72578-006
Application NumberANDA209966
Product Classification
M
Marketing Category
C73584
G
Generic Name
Modafinil
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (7)
MODAFINILActive
Quantity: 200 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
Modafinil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72578-005
Application NumberANDA209966
Product Classification
M
Marketing Category
C73584
G
Generic Name
Modafinil
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (7)
MODAFINILActive
Quantity: 100 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT