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 use Initial U.S. Approval: 1995
Approved
Approval ID
848cbcaf-2362-4da2-ae5c-9179aee21c0b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2023
Manufacturers
FDA
Breckenridge Pharmaceutical, Inc.
DUNS: 150554335
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexrazoxane Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51991-942
Application NumberANDA207321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexrazoxane Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 10, 2021
FDA Product Classification
INGREDIENTS (2)
Dexrazoxane HydrochlorideActive
Quantity: 500 mg in 50 mL
Code: 5346058Q7S
Classification: ACTIB
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT