NDC 35356-588

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 ID35356-588_436eb00e-1c46-4381-8e20-b0f9aea7d2e8
NDC35356-588
Product TypeHuman Prescription Drug
Proprietary NameNuvigil
Generic NameArmodafinil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-05-26
Marketing CategoryNDA / NDA
Application NumberNDA021875
Labeler NameLake Erie Medical DBA Quality Care Products LLC
Substance NameARMODAFINIL
Active Ingredient Strength250 mg/1
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 35356-588-30

30 TABLET in 1 BOTTLE (35356-588-30)
Marketing Start Date2014-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 35356-588-30 [35356058830]

Nuvigil TABLET
Marketing CategoryNDA
Application NumberNDA021875
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-03-04
Marketing End Date2019-10-11

NDC 35356-588-60 [35356058860]

Nuvigil TABLET
Marketing CategoryNDA
Application NumberNDA021875
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-03-03
Marketing End Date2019-10-11

Drug Details

Active Ingredients

IngredientStrength
ARMODAFINIL250 mg/1

OpenFDA Data

SPL SET ID:253f7061-449a-4824-8290-15827b14fe76
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 805661
  • 724861

    • 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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