Nuvigil
NUVIGIL (armodafinil) Tablets [C-IV]
Approved
Approval ID
10f918f7-4782-470e-a50e-35c7c66bfd79
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
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 Code42254-014
Application NumberNDA021875
Product Classification
M
Marketing Category
C73594
G
Generic Name
armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 8, 2010
FDA Product Classification
INGREDIENTS (7)
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
armodafinilActive
Quantity: 50 mg in 1 1
Code: V63XWA605I
Classification: ACTIM
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT