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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55700-510
Application NumberNDA021875
Product Classification
M
Marketing Category
C73605
G
Generic Name
Armodafinil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 29, 2019
FDA Product Classification
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