NDC 76310-002

Cardioxane

Dexrazoxane

Cardioxane is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Clinigen Healthcare Ltd. The primary component is Dexrazoxane Hydrochloride.

• Product ID: 76310-002_5a881549-9d86-4ff7-b4ab-2cfb315f9af3
• NDC: 76310-002
• Product Type: Human Prescription Drug
• Proprietary Name: Cardioxane
• Generic Name: Dexrazoxane
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-07-28
• Marketing Category: UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE / UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
• Labeler Name: Clinigen Healthcare Ltd
• Substance Name: DEXRAZOXANE HYDROCHLORIDE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cytoprotective Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 76310-002-01

1 VIAL, GLASS in 1 CARTON (76310-002-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

• Marketing Start Date: 2017-07-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76310-002-01 [76310000201]

Cardioxane INJECTION, POWDER, FOR SOLUTION

• Marketing Category: Unapproved drug for use in drug shor
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-07-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DEXRAZOXANE HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 16966fee-364e-4c76-b6ad-065d41a611e4
• Manufacturer:
  • Clinigen Healthcare Ltd
• UNII:
  • 5346058Q7S
• RxNorm Concept Unique ID - RxCUI:
  • 1939379
  • 1939374

Pharmacological Class

• Cytoprotective Agent [EPC]

NDC Crossover Matching brand name "Cardioxane" or generic name "Dexrazoxane"

NDC	Brand Name	Generic Name
76310-002	Cardioxane	dexrazoxane
0143-9247	Dexrazoxane	Dexrazoxane
0143-9248	Dexrazoxane	Dexrazoxane
55150-434	DEXRAZOXANE	DEXRAZOXANE
55150-437	DEXRAZOXANE	DEXRAZOXANE
67457-207	Dexrazoxane Hydrochloride	dexrazoxane
67457-208	Dexrazoxane Hydrochloride	dexrazoxane
0013-8717	Zinecard	dexrazoxane
0013-8727	Zinecard	dexrazoxane