MODAFINIL
Modafinil Tablets C-IV 200 mg
Approved
Approval ID
eba3a655-074b-46b3-88cf-3e6b2c0c8b15
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 14, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MODAFINIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42549-678
Application NumberNDA020717
Product Classification
M
Marketing Category
C73605
G
Generic Name
MODAFINIL
Product Specifications
Route of AdministrationORAL
Effective DateMay 14, 2012
FDA Product Classification
INGREDIENTS (7)
MODAFINILActive
Quantity: 200 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT