NUVIGIL
NUVIGIL (armodafinil) Tablets [C-IV]
Approved
Approval ID
795a7ba3-c60b-4637-aa99-06c1e10af8a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 8, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code16590-394
Application NumberNDA021875
Product Classification
M
Marketing Category
C73594
G
Generic Name
ARMODAFINIL
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2012
FDA Product Classification
INGREDIENTS (7)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ARMODAFINILActive
Quantity: 250 mg in 1 1
Code: V63XWA605I
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ARMODAFINIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-345
Application NumberNDA021875
Product Classification
M
Marketing Category
C73594
G
Generic Name
ARMODAFINIL
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2012
FDA Product Classification
INGREDIENTS (7)
ARMODAFINILActive
Quantity: 150 mg in 1 1
Code: V63XWA605I
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT