Modafinil
These highlights do not include all the information needed to use MODAFINIL TABLETS safely and effectively. See full prescribing information for MODAFINIL TABLETS. MODAFINIL tablets, for oral use, C-IV Initial U.S. Approval: 1998
Approved
Approval ID
01f6690c-1410-42ad-8eb3-e7df32eab3ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2022
Manufacturers
FDA
OrchidPharma Inc
DUNS: 809429207
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 Code42043-160
Application NumberANDA078963
Product Classification
M
Marketing Category
C73584
G
Generic Name
Modafinil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2022
FDA Product Classification
INGREDIENTS (9)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MODAFINILActive
Quantity: 100 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
Modafinil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42043-161
Application NumberANDA078963
Product Classification
M
Marketing Category
C73584
G
Generic Name
Modafinil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2022
FDA Product Classification
INGREDIENTS (9)
MODAFINILActive
Quantity: 200 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT