NDC 47781-578

Dexrazoxane

Dexrazoxane For Injection

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

Product ID47781-578_69464652-7d2a-e962-632a-d453274ade26
NDC47781-578
Product TypeHuman Prescription Drug
Proprietary NameDexrazoxane
Generic NameDexrazoxane For Injection
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA207321
Labeler NameAlvogen Inc.
Substance NameDEXRAZOXANE HYDROCHLORIDE
Active Ingredient Strength500 mg/50mL
Pharm ClassesCytoprotective Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47781-578-07

1 VIAL, SINGLE-DOSE in 1 CARTON (47781-578-07) > 50 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-09-01
Marketing End Date2021-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47781-578-07 [47781057807]

Dexrazoxane INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA207321
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-01

Drug Details

Active Ingredients

IngredientStrength
DEXRAZOXANE HYDROCHLORIDE500 mg/50mL

OpenFDA Data

SPL SET ID:2119c110-1803-1660-e330-7016625c5649
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1736590
    • UPC Code
  • 0347781578077

    • Pharmacological Class

    • Cytoprotective Agent [EPC]

    NDC Crossover Matching brand name "Dexrazoxane" or generic name "Dexrazoxane For Injection"

    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
    0013-8717Zinecarddexrazoxane
    0013-8727Zinecarddexrazoxane
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