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
f7c05bf9-816f-41e6-999d-bb3c7abd2627
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 23, 2023
Manufacturers
FDA
TWi Pharmaceuticals, Inc.
DUNS: 658402052
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 Code24979-160
Application NumberANDA214289
Product Classification
M
Marketing Category
C73584
G
Generic Name
mycophenolic acid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2022
FDA Product Classification
INGREDIENTS (16)
MYCOPHENOLATE SODIUMActive
Quantity: 180 mg in 1 1
Code: WX877SQI1G
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
mycophenolic acid
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-161
Application NumberANDA214289
Product Classification
M
Marketing Category
C73584
G
Generic Name
mycophenolic acid
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2022
FDA Product Classification
INGREDIENTS (14)
MYCOPHENOLATE SODIUMActive
Quantity: 360 mg in 1 1
Code: WX877SQI1G
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT