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
f51ca007-3955-4540-a88a-0ddae8d8e8ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 11, 2021
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 2
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 Code65862-602
Application NumberANDA202566
Product Classification
M
Marketing Category
C73584
G
Generic Name
Modafinil
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2021
FDA Product Classification
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
Modafinil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65862-601
Application NumberANDA202566
Product Classification
M
Marketing Category
C73584
G
Generic Name
Modafinil
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 11, 2021
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MODAFINILActive
Quantity: 100 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT