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
26b31126-4262-4a15-8a16-234c86763176
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code68084-907
Application NumberANDA091558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mycophenolic Acid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (12)
METHYLCELLULOSE (400 MPA.S)Inactive
Code: O0GN6F9B2Y
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MYCOPHENOLATE SODIUMActive
Quantity: 180 mg in 1 1
Code: WX877SQI1G
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Mycophenolic Acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68084-918
Application NumberANDA091558
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mycophenolic Acid
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (13)
METHYLCELLULOSE (400 MPA.S)Inactive
Code: O0GN6F9B2Y
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MYCOPHENOLATE SODIUMActive
Quantity: 360 mg in 1 1
Code: WX877SQI1G
Classification: ACTIM