Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PSS World Medical Inc.
101822682
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
STAT Rx USA LLC
STAT Rx USA LLC
PSS World Medical Inc.
786036330
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NUVIGIL
Product Details
NDC Product Code
16590-394Application Number
NDA021875Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 26, 2012CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ArmodafinilActive
Code: V63XWA605IClass: ACTIMQuantity: 250 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
NUVIGIL
Product Details
NDC Product Code
16590-345Application Number
NDA021875Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 26, 2012ArmodafinilActive
Code: V63XWA605IClass: ACTIMQuantity: 150 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT