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-IVInitial U.S. Approval: 2007
Approved
Approval ID
98338994-7818-4b86-ae98-cd08fa700879
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2023
Manufacturers
FDA
Quality Care Products LLC
DUNS: 831276758
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Armodafinil
PRODUCT DETAILS
NDC Product Code55700-510
Application NumberNDA021875
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateAugust 29, 2019
Generic NameArmodafinil
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ARMODAFINILActive
Quantity: 250 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT