NDC 63323-572

CLOFARABINE

Clofarabine

CLOFARABINE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Fresenius-kabi. The primary component is Clofarabine.

Product ID63323-572_171fac5c-1ab6-47d5-87d5-d23171f33cbd
NDC63323-572
Product TypeHuman Prescription Drug
Proprietary NameCLOFARABINE
Generic NameClofarabine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-05-10
Marketing CategoryANDA / ANDA
Application NumberANDA204029
Labeler NameFresenius-Kabi
Substance NameCLOFARABINE
Active Ingredient Strength1 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63323-572-70

1 VIAL, SINGLE-USE in 1 CARTON (63323-572-70) > 20 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2017-05-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-572-70 [63323057270]

CLOFARABINE INJECTION
Marketing CategoryANDA
Application NumberANDA204029
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-05-10

Drug Details

Active Ingredients

IngredientStrength
CLOFARABINE1 mg/mL

OpenFDA Data

SPL SET ID:fe6ff0f9-7610-4a69-9b75-da7ec4bb7744
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 486419
  • UPC Code
  • 0363323572709
  • Pharmacological Class

    • Nucleic Acid Synthesis Inhibitors [MoA]
    • Nucleoside Metabolic Inhibitor [EPC]

    NDC Crossover Matching brand name "CLOFARABINE" or generic name "Clofarabine"

    NDCBrand NameGeneric Name
    0955-1746clofarabineclofarabine
    43598-309ClofarabineClofarabine
    49315-003CLOFARABINEclofarabine
    50742-512CLOFARABINEclofarabine
    55150-326CLOFARABINECLOFARABINE
    60505-6166Clofarabineclofarabine
    63323-572CLOFARABINEclofarabine
    67457-546clofarabineclofarabine
    68083-386ClofarabineClofarabine
    70121-1236ClofarabineClofarabine
    71288-128ClofarabineClofarabine
    72266-108CLOFARABINECLOFARABINE
    0024-5860Clolarclofarabine
    0024-5917Clolarclofarabine

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.