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 use Initial U.S. Approval: 1995
Approved
Approval ID
a6275064-8523-43fa-8ab1-a34009ac93eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 11, 2023
Manufacturers
FDA
Steriscience Pte. Limited
DUNS: 659844097
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 Code81293-000
Application NumberANDA216390
Product Classification
M
Marketing Category
C73584
G
Generic Name
mycophenolate mofetil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 11, 2023
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MYCOPHENOLATE MOFETILActive
Quantity: 500 mg in 20 mL
Code: 9242ECW6R0
Classification: ACTIB