Mycophenolic Acid
These highlights do not include all the information needed to use MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for MYCOPHENOLIC ACID DELAYED-RELEASE TABLETS. MYCOPHENOLIC ACID delayed-release tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
54ede764-11de-4103-8456-9fd5d1889d3d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2021
Manufacturers
FDA
AMTA LABS LIMITED
DUNS: 664424833
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 Code72322-1049
Application NumberANDA214376
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mycophenolic Acid
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2021
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MYCOPHENOLATE SODIUMActive
Quantity: 360 mg in 1 1
Code: WX877SQI1G
Classification: ACTIM
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Mycophenolic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72322-1048
Application NumberANDA214376
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mycophenolic Acid
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2021
FDA Product Classification
INGREDIENTS (15)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1--ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
GLYCERYL MONO AND DICAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYVINYL ALCOHOL GRAFT POLYETHYLENE GLYCOL COPOLYMER (3:1; 45000 MW)Inactive
Code: 23ZQ42JZZH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MYCOPHENOLATE SODIUMActive
Quantity: 180 mg in 1 1
Code: WX877SQI1G
Classification: ACTIM