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
47e14e11-b072-410c-8061-e70631b3bfc8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 18, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
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 Code70121-1584
Application NumberANDA211374
Product Classification
M
Marketing Category
C73584
G
Generic Name
mycophenolate mofetil
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 18, 2023
FDA Product Classification
INGREDIENTS (7)
MYCOPHENOLATE MOFETILActive
Quantity: 500 mg in 20 mL
Code: 9242ECW6R0
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT