Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Myfortic
Product Details
NDC Product Code
0078-0386Application Number
NDA050791Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 19, 2016Mycophenolic acidActive
Code: WX877SQI1GClass: ACTIMQuantity: 360 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
Myfortic
Product Details
NDC Product Code
0078-0385Application Number
NDA050791Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 19, 2016Mycophenolic acidActive
Code: WX877SQI1GClass: ACTIMQuantity: 180 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT