Modafinil
{'content': {'@styleCode': 'bold', 'content': [{'@styleCode': 'bold', 'br': None, '#text': 'These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS.'}, {'@styleCode': 'bold', 'br': None, '#text': 'MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998'}], 'br': [None, None, None]}}
Approved
Approval ID
a4a27496-0f5a-4ea8-b48c-72fcb323dc8f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2023
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 Code71610-685
Application NumberANDA077667
Product Classification
M
Marketing Category
C73584
G
Generic Name
modafinil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2023
FDA Product Classification
INGREDIENTS (5)
MODAFINILActive
Quantity: 200 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT