NDC 51991-942

Dexrazoxane

Dexrazoxane Hydrochloride

Dexrazoxane is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Dexrazoxane Hydrochloride.

Product ID51991-942_3cf93d43-a779-4d9a-9ef5-1648e6ffa278
NDC51991-942
Product TypeHuman Prescription Drug
Proprietary NameDexrazoxane
Generic NameDexrazoxane Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-12-05
Marketing CategoryANDA / ANDA
Application NumberANDA207321
Labeler NameBreckenridge Pharmaceutical, Inc.
Substance NameDEXRAZOXANE HYDROCHLORIDE
Active Ingredient Strength500 mg/50mL
Pharm ClassesCytoprotective Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 51991-942-98

1 VIAL, SINGLE-DOSE in 1 CARTON (51991-942-98) > 50 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51991-942-98 [51991094298]

Dexrazoxane INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207321
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-06-26

Drug Details

Active Ingredients

IngredientStrength
DEXRAZOXANE HYDROCHLORIDE500 mg/50mL

OpenFDA Data

SPL SET ID:848cbcaf-2362-4da2-ae5c-9179aee21c0b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1736590

    • Pharmacological Class

    • Cytoprotective Agent [EPC]
    • Cytoprotective Agent [EPC]

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

    NDCBrand NameGeneric Name
    0143-9247DexrazoxaneDexrazoxane
    0143-9248DexrazoxaneDexrazoxane
    47781-578DexrazoxaneDexrazoxane for Injection
    51991-942DexrazoxaneDexrazoxane Hydrochloride
    55150-434DEXRAZOXANEDEXRAZOXANE
    55150-437DEXRAZOXANEDEXRAZOXANE
    68083-195DexrazoxaneDexrazoxane for Injection
    72266-101DexrazoxaneDexrazoxane for Injection
    72266-235DexrazoxaneDexrazoxane for Injection
    72611-716DexrazoxaneDexrazoxane for Injection
    76310-002Cardioxanedexrazoxane
    67457-207Dexrazoxane Hydrochloridedexrazoxane
    67457-208Dexrazoxane Hydrochloridedexrazoxane
    66220-110Totectdexrazoxane hydrochloride
    76310-110Totectdexrazoxane hydrochloride
    0013-8717Zinecarddexrazoxane
    0013-8727Zinecarddexrazoxane
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