Mycophenolate Mofetil
These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL TABLETS safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL TABLETS.MYCOPHENOLATE mofetil tablets, for oral useInitial U.S. Approval: 1995
Approved
Approval ID
e34c14d1-8d6e-4c21-922d-60ea10fa4b78
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 22, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 022629579
Products 1
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 Code0480-3571
Application NumberANDA065451
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mycophenolate Mofetil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2022
FDA Product Classification
INGREDIENTS (12)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
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
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT