ARMODAFINIL
ARMODAFINIL
Approved
Approval ID
ddd06dab-0855-5b4e-e053-2a95a90a5e67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 19, 2022
Manufacturers
FDA
DirectRx
DUNS: 079254320
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 Code72189-353
Application NumberNDA021875
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateMay 19, 2022
Generic NameARMODAFINIL
INGREDIENTS (7)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ARMODAFINILActive
Quantity: 200 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT