NDC 67457-546

clofarabine

Clofarabine

clofarabine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Clofarabine.

Product ID67457-546_1f8ac128-c25d-41f4-9f90-410a792acd66
NDC67457-546
Product TypeHuman Prescription Drug
Proprietary Nameclofarabine
Generic NameClofarabine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-11-06
Marketing CategoryANDA / ANDA
Application NumberANDA208860
Labeler NameMylan Institutional LLC
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 67457-546-20

1 VIAL, SINGLE-DOSE in 1 CARTON (67457-546-20) > 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2017-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-546-20 [67457054620]

clofarabine INJECTION
Marketing CategoryANDA
Application NumberANDA208860
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-11-06

Drug Details

Active Ingredients

IngredientStrength
CLOFARABINE1 mg/mL

OpenFDA Data

SPL SET ID:1f8ac128-c25d-41f4-9f90-410a792acd66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 486419
  • 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

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