ARMODAFINIL
ARMODAFINIL
Approved
Approval ID
b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2021
Manufacturers
FDA
direct rx
DUNS: 079254320
Products 2
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 Code72189-261
Application NumberNDA021875
Product Classification
M
Marketing Category
C73605
G
Generic Name
ARMODAFINIL
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2021
FDA Product Classification
INGREDIENTS (7)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ARMODAFINILActive
Quantity: 250 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
ARMODAFINIL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72189-133
Application NumberANDA206069
Product Classification
M
Marketing Category
C73584
G
Generic Name
ARMODAFINIL
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2021
FDA Product Classification
INGREDIENTS (5)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ARMODAFINILActive
Quantity: 250 mg in 1 1
Code: V63XWA605I
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT