NDC 0143-9248

Dexrazoxane

Dexrazoxane

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

Product ID0143-9248_2c71aef6-33cc-4f1d-acba-8a2c4c6bce95
NDC0143-9248
Product TypeHuman Prescription Drug
Proprietary NameDexrazoxane
Generic NameDexrazoxane
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2005-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA076068
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameDEXRAZOXANE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesCytoprotective Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0143-9248-01

1 VIAL in 1 BOX (0143-9248-01) > 50 mL in 1 VIAL
Marketing Start Date2017-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9248-01 [00143924801]

Dexrazoxane INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA076068
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-05

Drug Details

Active Ingredients

IngredientStrength
DEXRAZOXANE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:68089182-d4a2-4053-8d0d-fc97a901515d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1736590
  • 1736585

    • Pharmacological Class

    • Cytoprotective Agent [EPC]

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

    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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