Mycophenolate Mofetil
These highlights do not include all the information needed to use MYCOPHENOLATE MOFETIL FOR INJECTION safely and effectively. See full prescribing information for MYCOPHENOLATE MOFETIL FOR INJECTION.MYCOPHENOLATE MOFETIL for injection, for intravenous useInitial U.S. Approval: 1995
Approved
Approval ID
432dbc25-da17-4c99-8d52-f45cb7460232
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
Akorn
DUNS: 117693100
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 Code17478-957
Application NumberANDA204043
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mycophenolate Mofetil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 25, 2024
FDA Product Classification
INGREDIENTS (7)
Mycophenolate MofetilActive
Quantity: 500 mg in 20 mL
Code: 9242ECW6R0
Classification: ACTIB
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT