NDC 72266-108

CLOFARABINE

Clofarabine

CLOFARABINE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Fosun Pharma Usa Inc.. The primary component is Clofarabine.

Product ID72266-108_8c67d5f8-f1c5-8045-e053-2995a90af8b4
NDC72266-108
Product TypeHuman Prescription Drug
Proprietary NameCLOFARABINE
Generic NameClofarabine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-08-19
Marketing CategoryANDA / ANDA
Application NumberANDA207831
Labeler NameFosun Pharma USA Inc.
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 72266-108-01

1 VIAL, SINGLE-DOSE in 1 CARTON (72266-108-01) > 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-08-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72266-108-01 [72266010801]

CLOFARABINE INJECTION
Marketing CategoryANDA
Application NumberANDA207831
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-19

Drug Details

Active Ingredients

IngredientStrength
CLOFARABINE1 mg/mL

OpenFDA Data

SPL SET ID:e956b1e0-2829-4872-8c09-99462d60e922
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 486419
  • Pharmacological Class

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