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 Initial U.S. Approval: 1995
Approved
Approval ID
a7c01089-85f5-40aa-b679-f53a425b4d68
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
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 Code72205-248
Application NumberANDA216748
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexrazoxane
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (2)
DEXRAZOXANE HYDROCHLORIDEActive
Quantity: 500 mg in 50 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 Code72205-247
Application NumberANDA216748
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexrazoxane
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (2)
DEXRAZOXANE HYDROCHLORIDEActive
Quantity: 250 mg in 25 mL
Code: 5346058Q7S
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT