NDC 68083-195

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 Gland Pharma Limited. The primary component is Dexrazoxane Hydrochloride.

Product ID68083-195_9a0e54ca-a444-4474-94fc-0b4ac5b0e394
NDC68083-195
Product TypeHuman Prescription Drug
Proprietary NameDexrazoxane
Generic NameDexrazoxane For Injection
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-12-05
Marketing CategoryANDA / ANDA
Application NumberANDA207321
Labeler NameGland Pharma Limited
Substance NameDEXRAZOXANE HYDROCHLORIDE
Active Ingredient Strength500 mg/50mL
Pharm ClassesCytoprotective Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-195-01

1 VIAL in 1 CARTON (68083-195-01) > 50 mL in 1 VIAL
Marketing Start Date2016-12-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-195-01 [68083019501]

Dexrazoxane INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA207321
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-05

Drug Details

Active Ingredients

IngredientStrength
DEXRAZOXANE HYDROCHLORIDE500 mg/50mL

OpenFDA Data

SPL SET ID:c9c625fc-8852-4ed4-bcf2-63f46a706782
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1736590
    • UPC Code
  • 0368083195014

    • Pharmacological Class

    • Cytoprotective Agent [EPC]
    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.