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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

944daf47-49a6-93ca-e348-4a0f1b6d937e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 4, 2023

Manufacturers
FDA

Apotex Corp.

DUNS: 845263701

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 Code60505-2526
Application NumberANDA077667
Product Classification
M
Marketing Category
C73584
G
Generic Name
modafinil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification

INGREDIENTS (5)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MODAFINILActive
Quantity: 100 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLCELLULOSE (15 MPA.S)Inactive
Code: NPU9M2E6L8
Classification: IACT

modafinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-2527
Application NumberANDA077667
Product Classification
M
Marketing Category
C73584
G
Generic Name
modafinil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification

INGREDIENTS (5)

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
MODAFINILActive
Quantity: 200 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB

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Modafinil - FDA Drug Approval Details