Dexrazoxane
These highlights do not include all the information needed to use DEXRAZOXANE FOR INJECTION safely and effectively. See full prescribing information for DEXRAZOXANE FOR INJECTION. DEXRAZOXANE for Injection for [Route of Administration] use Initial U.S. Approval: 1995
Approved
Approval ID
68089182-d4a2-4053-8d0d-fc97a901515d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2019
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexrazoxane
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9247
Application NumberANDA076068
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexrazoxane
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 13, 2018
FDA Product Classification
INGREDIENTS (2)
DEXRAZOXANE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 5346058Q7S
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Dexrazoxane
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9248
Application NumberANDA076068
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexrazoxane
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 13, 2018
FDA Product Classification
INGREDIENTS (2)
DEXRAZOXANE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 5346058Q7S
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT