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 ID76310-002_5a881549-9d86-4ff7-b4ab-2cfb315f9af3
NDC76310-002
Product TypeHuman Prescription Drug
Proprietary NameCardioxane
Generic NameDexrazoxane
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-07-28
Marketing CategoryUNAPPROVED DRUG FOR USE IN DRUG SHORTAGE / UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Labeler NameClinigen Healthcare Ltd
Substance NameDEXRAZOXANE HYDROCHLORIDE
Active Ingredient Strength500 mg/1
Pharm ClassesCytoprotective Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

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 Date2017-07-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76310-002-01 [76310000201]

Cardioxane INJECTION, POWDER, FOR SOLUTION
Marketing CategoryUnapproved drug for use in drug shor
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXRAZOXANE HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:16966fee-364e-4c76-b6ad-065d41a611e4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1939379
  • 1939374
  • Pharmacological Class

    • Cytoprotective Agent [EPC]

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

    NDCBrand NameGeneric Name
    76310-002Cardioxanedexrazoxane
    0143-9247DexrazoxaneDexrazoxane
    0143-9248DexrazoxaneDexrazoxane
    55150-434DEXRAZOXANEDEXRAZOXANE
    55150-437DEXRAZOXANEDEXRAZOXANE
    67457-207Dexrazoxane Hydrochloridedexrazoxane
    67457-208Dexrazoxane Hydrochloridedexrazoxane
    0013-8717Zinecarddexrazoxane
    0013-8727Zinecarddexrazoxane

    Trademark Results [Cardioxane]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CARDIOXANE
    CARDIOXANE
    86969771 5561522 Live/Registered
    Clinigen Healthcare Limited
    2016-04-08
    CARDIOXANE
    CARDIOXANE
    85885417 not registered Dead/Abandoned
    Clinigen Healthcare Limited
    2013-03-25

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