Modafinil
These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, CIV Initial U.S. Approval: 1998
Approved
Approval ID
d97684d7-c236-451e-99bd-b8df4bf36643
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2023
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Modafinil
PRODUCT DETAILS
NDC Product Code71205-544
Application NumberANDA202566
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 1, 2023
Generic NameModafinil
INGREDIENTS (5)
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
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT