Modafinil
These highlights do not include all the information needed to use modafinil safely and effectively. See full prescribing information for modafinil. Initial U.S. Approval: 1998
Approved
Approval ID
6a8a2185-52f9-4952-a361-514e44b1cd44
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 6, 2016
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code43353-956
Application NumberNDA020717
Product Classification
M
Marketing Category
C73605
G
Generic Name
Modafinil
Product Specifications
Route of AdministrationORAL
Effective DateJuly 18, 2014
FDA Product Classification
INGREDIENTS (7)
MODAFINILActive
Quantity: 200 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT