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-IV Initial U.S. Approval: 2007
Approved
Approval ID
de2f0921-e791-426c-9192-2b7162e2158c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Natco Pharma USA LLC
DUNS: 079590418
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Armodafinil
PRODUCT DETAILS
NDC Product Code69339-177
Application NumberANDA202768
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 20, 2023
Generic NameArmodafinil
INGREDIENTS (6)
ARMODAFINILActive
Quantity: 50 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
Armodafinil
PRODUCT DETAILS
NDC Product Code69339-179
Application NumberANDA202768
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 20, 2023
Generic NameArmodafinil
INGREDIENTS (6)
ARMODAFINILActive
Quantity: 200 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Armodafinil
PRODUCT DETAILS
NDC Product Code69339-178
Application NumberANDA202768
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 20, 2023
Generic NameArmodafinil
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ARMODAFINILActive
Quantity: 150 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
Armodafinil
PRODUCT DETAILS
NDC Product Code69339-180
Application NumberANDA202768
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 20, 2023
Generic NameArmodafinil
INGREDIENTS (6)
ARMODAFINILActive
Quantity: 250 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT