Modafinil
MODAFINIL TABLETS CIV
Approved
Approval ID
f39820fb-8248-4d42-854c-6fe2d9b92d36
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1052
Application NumberANDA209966
Product Classification
M
Marketing Category
C73584
G
Generic Name
Modafinil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (7)
MODAFINILActive
Quantity: 200 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Modafinil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1051
Application NumberANDA209966
Product Classification
M
Marketing Category
C73584
G
Generic Name
Modafinil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (7)
MODAFINILActive
Quantity: 100 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT