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 intravenous useInitial U.S. Approval: 1995
Approved
Approval ID
9cbd2987-10bb-eceb-153d-ee7be1ed0c84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2022
Manufacturers
FDA
Almaject, Inc.
DUNS: 116626205
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexrazoxane for Injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72611-716
Application NumberANDA207321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexrazoxane for Injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 1, 2016
FDA Product Classification
INGREDIENTS (2)
DEXRAZOXANE HYDROCHLORIDEActive
Quantity: 500 mg in 50 mL
Code: 5346058Q7S
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT