Modafinil
{'content': {'@styleCode': 'bold', 'content': [{'@styleCode': 'bold', 'br': None, '#text': 'These highlights do not include all the information needed to use MODAFINIL TABLETS, USP safely and effectively. See full prescribing information for MODAFINIL TABLETS, USP.'}, {'@styleCode': 'bold', 'br': None, '#text': 'MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998'}], 'br': [None, None, None]}}
Approved
Approval ID
3f6959c8-1707-4452-9de3-2f329b6a6e41
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 16, 2021
Manufacturers
FDA
Quality Care Products, LLC
DUNS: 831276758
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 Code55700-695
Application NumberANDA077667
Product Classification
M
Marketing Category
C73584
G
Generic Name
modafinil
Product Specifications
Route of AdministrationORAL
Effective DateNovember 20, 2018
FDA Product Classification
INGREDIENTS (5)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHYLCELLULOSE (15 CPS)Inactive
Code: NPU9M2E6L8
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MODAFINILActive
Quantity: 200 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB