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 t ablets for oral use, C-IV Initial U.S. Approval: 1998
Approved
Approval ID
d2558a46-b482-494c-9d86-f883dc30f14b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 24, 2018
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-3865
Application NumberANDA076715
Product Classification
M
Marketing Category
C73584
G
Generic Name
Modafinil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 31, 2016
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MODAFINILActive
Quantity: 100 mg in 1 1
Code: R3UK8X3U3D
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT