NDC 43353-015

Azilect

Rasagiline Mesylate

Azilect is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Rasagiline Mesylate.

Product ID43353-015_7a05b579-97d9-4b52-8998-b95a634e674e
NDC43353-015
Product TypeHuman Prescription Drug
Proprietary NameAzilect
Generic NameRasagiline Mesylate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2006-07-10
Marketing CategoryNDA / NDA
Application NumberNDA021641
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameRASAGILINE MESYLATE
Active Ingredient Strength1 mg/1
Pharm ClassesMonoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 43353-015-18

3000 TABLET in 1 BOTTLE (43353-015-18)
Marketing Start Date2015-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-015-18 [43353001518]

Azilect TABLET
Marketing CategoryNDA
Application NumberNDA021641
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
RASAGILINE MESYLATE1 mg/1

OpenFDA Data

SPL SET ID:73efe275-acea-49c0-aa76-fdc4249c424e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 608328
  • 637185

    • Pharmacological Class

    • Monoamine Oxidase Inhibitor [EPC]
    • Monoamine Oxidase Inhibitors [MoA]

    NDC Crossover Matching brand name "Azilect" or generic name "Rasagiline Mesylate"

    NDCBrand NameGeneric Name
    43353-015AzilectRasagiline Mesylate
    68546-142AzilectRasagiline mesylate
    68546-229AzilectRasagiline mesylate
    0378-1270Rasagiline Mesylaterasagiline mesylate
    0378-1271Rasagiline Mesylaterasagiline mesylate
    14445-104Rasagiline MesylateRasagiline Mesylate
    14445-105Rasagiline MesylateRasagiline Mesylate
    23155-746Rasagiline MesylateRasagiline Mesylate
    23155-747Rasagiline MesylateRasagiline Mesylate
    47781-138Rasagiline MesylateRasagiline Mesylate
    47781-139Rasagiline MesylateRasagiline Mesylate

    Trademark Results [Azilect]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AZILECT
    AZILECT
    78279632 2899711 Live/Registered
    Teva Pharmaceutical Industries Ltd.
    2003-07-28
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