NDC 35356-589

Nuvigil

Armodafinil

Nuvigil is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Armodafinil.

Product ID35356-589_5270f354-e5f6-4e9b-824b-e3b4f92178a1
NDC35356-589
Product TypeHuman Prescription Drug
Proprietary NameNuvigil
Generic NameArmodafinil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-06-01
Marketing CategoryNDA / NDA
Application NumberNDA021875
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameARMODAFINIL
Active Ingredient Strength150 mg/1
DEA ScheduleCIV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 35356-589-30

30 TABLET in 1 BOTTLE (35356-589-30)
Marketing Start Date2009-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-589-30 [35356058930]

Nuvigil TABLET
Marketing CategoryNDA
Application NumberNDA021875
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-06-01
Marketing End Date2018-12-31

Drug Details

Active Ingredients

IngredientStrength
ARMODAFINIL150 mg/1

OpenFDA Data

SPL SET ID:0310a062-51fd-4e74-8a5f-7f21a16f52c9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 724859
  • 805659

    • NDC Crossover Matching brand name "Nuvigil" or generic name "Armodafinil"

    NDCBrand NameGeneric Name
    35356-588NuvigilNuvigil
    35356-589NuvigilNuvigil
    42254-014NuvigilNuvigil
    63459-220NuvigilNuvigil
    63459-225NuvigilNuvigil
    63459-205NuvigilNuvigil
    63459-215NuvigilNuvigil
    0093-3090ArmodafinilArmodafinil
    0093-3092ArmodafinilArmodafinil
    0093-3093ArmodafinilArmodafinil
    0093-3094ArmodafinilArmodafinil
    0378-3431Armodafinilarmodafinil
    0378-3432Armodafinilarmodafinil
    0378-3433Armodafinilarmodafinil
    0591-3856ArmodafinilArmodafinil
    0781-8029ArmodafinilArmodafinil
    0781-8037ArmodafinilArmodafinil
    0781-8045ArmodafinilArmodafinil

    Trademark Results [Nuvigil]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NUVIGIL
    NUVIGIL
    78426061 3538564 Live/Registered
    Cephalon, Inc.
    2004-05-27
    NUVIGIL
    NUVIGIL
    77668359 3782440 Live/Registered
    Cephalon, Inc.
    2009-02-11
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