Myfortic
These highlights do not include all the information needed to use MYFORTIC safely and effectively. See full prescribing information for MYFORTIC. MYFORTIC (mycophenolic acid) delayed-release tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
eed26501-890d-4ff6-88e7-6dbea4726e53
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mycophenolic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0386
Application NumberNDA050791
Product Classification
M
Marketing Category
C73594
G
Generic Name
mycophenolic acid
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2016
FDA Product Classification
INGREDIENTS (11)
MYCOPHENOLATE SODIUMActive
Quantity: 360 mg in 1 1
Code: WX877SQI1G
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
mycophenolic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0385
Application NumberNDA050791
Product Classification
M
Marketing Category
C73594
G
Generic Name
mycophenolic acid
Product Specifications
Route of AdministrationORAL
Effective DateApril 19, 2016
FDA Product Classification
INGREDIENTS (11)
MYCOPHENOLATE SODIUMActive
Quantity: 180 mg in 1 1
Code: WX877SQI1G
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT