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 CIVInitial U.S. Approval: 2007
Approved
Approval ID
de0799f7-7644-4057-a7da-75436f978c61
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 17, 2018
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 3
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 Code0378-3432
Application NumberANDA200043
Product Classification
M
Marketing Category
C73584
G
Generic Name
armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
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
armodafinil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-3433
Application NumberANDA200043
Product Classification
M
Marketing Category
C73584
G
Generic Name
armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (6)
ARMODAFINILActive
Quantity: 250 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
armodafinil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-3431
Application NumberANDA200043
Product Classification
M
Marketing Category
C73584
G
Generic Name
armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
ARMODAFINILActive
Quantity: 50 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT