Mesna
These highlights do not include all the information needed to use MESNA INJECTION safely and effectively. See full prescribing information for MESNA INJECTION. MESNA injection, for intravenous use Initial U.S. Approval: 1988
Approved
Approval ID
ef161ede-0451-43c8-b0e5-cb108b138e38
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 22, 2019
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MESNA
PRODUCT DETAILS
NDC Product Code63323-733
Application NumberANDA075811
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateApril 22, 2019
Generic NameMESNA
INGREDIENTS (4)
MESNAActive
Quantity: 100 mg in 1 mL
Code: NR7O1405Q9
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 10.4 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.25 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT