NDC 0078-0683

Arranon

Nelarabine

Arranon is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Nelarabine.

Product ID0078-0683_3616a9ae-3037-42aa-825f-78628639e3e9
NDC0078-0683
Product TypeHuman Prescription Drug
Proprietary NameArranon
Generic NameNelarabine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-10-05
Marketing CategoryNDA / NDA
Application NumberNDA021877
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameNELARABINE
Active Ingredient Strength5 mg/mL
Pharm ClassesNucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0683-06

6 VIAL in 1 CARTON (0078-0683-06) > 50 mL in 1 VIAL
Marketing Start Date2016-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0683-06 [00078068306]

Arranon INJECTION
Marketing CategoryNDA
Application NumberNDA021877
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-10-05

NDC 0078-0683-61 [00078068361]

Arranon INJECTION
Marketing CategoryNDA
Application NumberNDA021877
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-02

Drug Details

Active Ingredients

IngredientStrength
NELARABINE5 mg/mL

OpenFDA Data

SPL SET ID:fffa5d75-0dba-4ad7-a252-5f60fa28489a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 603566
  • 616366
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Arranon" or generic name "Nelarabine"

    NDCBrand NameGeneric Name
    0078-0683Arranonnelarabine
    43598-142NelarabineNelarabine
    70710-1726NelarabineNelarabine
    70710-1839NelarabineNelarabine
    70771-1685NelarabineNelarabine

    Trademark Results [Arranon]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ARRANON
    ARRANON
    78325294 2901813 Live/Registered
    NOVARTIS PHARMA AG
    2003-11-10
    ARRANON
    ARRANON
    78226967 2877259 Dead/Cancelled
    GLAXOSMITHKLINE LLC
    2003-03-18

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