MESNA
These highlights do not include all the information needed to use mesna safely and effectively. See full prescribing information for mesna. MESNEX (mesna) tablets, for oral use Mesna injection, for intravenous useInitial U.S. Approval: 1988
Approved
Approval ID
a880160b-fa82-453a-a971-29ab897876a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 17, 2018
Manufacturers
FDA
Baxter Healthcare Corporation
DUNS: 005083209
FDA
Baxter Healthcare Company
DUNS: 005083209
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 Code10019-951
Application NumberNDA019884
Product Classification
M
Marketing Category
C73594
G
Generic Name
MESNA
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 18, 2018
FDA Product Classification
INGREDIENTS (4)
SODIUM HYDROXIDEInactive
Quantity: 0.25 mg in 1 mL
Code: 55X04QC32I
Classification: IACT
MESNAActive
Quantity: 100 mg in 1 mL
Code: NR7O1405Q9
Classification: ACTIB
EDETATE DISODIUMInactive
Quantity: 0.25 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 10.40 mg in 1 mL
Code: LKG8494WBH
Classification: IACT