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 useInitial U.S. Approval: 1988
Approved
Approval ID
2a2a526f-636b-7920-4261-6c626f612a2a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2021
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 796852890
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mesna
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-201
Application NumberANDA090913
Product Classification
M
Marketing Category
C73584
G
Generic Name
mesna
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 21, 2019
FDA Product Classification
INGREDIENTS (5)
mesnaActive
Quantity: 100 mg in 1 mL
Code: NR7O1405Q9
Classification: ACTIB
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT