Mycophenolate Mofetil
These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL.MYCOPHENOLATE mofetil capsules, for oral useMYCOPHENOLATE mofetil tablets, for oral useInitial U.S. Approval: 1995
Approved
Approval ID
99b2eb58-8d14-48fc-bbe1-aacb711a783e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2022
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mycophenolate Mofetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-2067
Application NumberANDA065379
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mycophenolate Mofetil
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2022
FDA Product Classification
INGREDIENTS (17)
MYCOPHENOLATE MOFETILActive
Quantity: 250 mg in 1 1
Code: 9242ECW6R0
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
Mycophenolate Mofetil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-5175
Application NumberANDA065451
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mycophenolate Mofetil
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2022
FDA Product Classification
INGREDIENTS (12)
MYCOPHENOLATE MOFETILActive
Quantity: 500 mg in 1 1
Code: 9242ECW6R0
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT