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Armodafinil

These highlights do not include all the information needed to use ARMODAFINIL TABLETS safely and effectively. See full prescribing information for ARMODAFINIL TABLETS. ARMODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 2007

Approved
Approval ID

de2f0921-e791-426c-9192-2b7162e2158c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 5, 2023

Manufacturers
FDA

Natco Pharma USA LLC

DUNS: 079590418

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Armodafinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69339-177
Application NumberANDA202768
Product Classification
M
Marketing Category
C73584
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (6)

ARMODAFINILActive
Quantity: 50 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT

Armodafinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69339-179
Application NumberANDA202768
Product Classification
M
Marketing Category
C73584
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (6)

ARMODAFINILActive
Quantity: 200 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT

Armodafinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69339-178
Application NumberANDA202768
Product Classification
M
Marketing Category
C73584
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (6)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ARMODAFINILActive
Quantity: 150 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT

Armodafinil

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69339-180
Application NumberANDA202768
Product Classification
M
Marketing Category
C73584
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification

INGREDIENTS (6)

ARMODAFINILActive
Quantity: 250 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT

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