mesna
These highlights do not include all the information needed to use MESNA INJECTION safely and effectively. See full prescribing information for MESNA INJECTION.Initial U.S. Approval:1988
Approved
Approval ID
8012b97b-4e39-451f-8e04-542d196e8bc6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
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 Code0143-9260
Application NumberANDA075739
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMay 3, 2023
Generic Namemesna
INGREDIENTS (5)
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
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT