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, CIV Initial U.S. Approval: 2007
Approved
Approval ID
cbe7c0d9-dfd2-4000-bd76-7fe3454ce64f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 2
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 Code71335-1193
Application NumberANDA206069
Product Classification
M
Marketing Category
C73584
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2018
FDA Product Classification
INGREDIENTS (5)
ARMODAFINILActive
Quantity: 150 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
Armodafinil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71335-1308
Application NumberANDA206069
Product Classification
M
Marketing Category
C73584
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2018
FDA Product Classification
INGREDIENTS (5)
ARMODAFINILActive
Quantity: 250 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT