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
32001417-130d-4c08-8e63-94ba3627ce5f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
BPI Labs LLC
DUNS: 078627620
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mycophenolate Mofetil hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54288-141
Application NumberANDA214283
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mycophenolate Mofetil hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MYCOPHENOLATE MOFETIL HYDROCHLORIDEActive
Quantity: 500 mg in 20 mL
Code: UXH81S8ZVB
Classification: ACTIR
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT