NDC 68258-7049

Lunesta

Eszopiclone

Lunesta is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Eszopiclone.

Product ID68258-7049_abf41383-30a2-43ec-b4d3-1c17836b8900
NDC68258-7049
Product TypeHuman Prescription Drug
Proprietary NameLunesta
Generic NameEszopiclone
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2005-04-04
Marketing CategoryNDA / NDA
Application NumberNDA021476
Labeler NameDispensing Solutions, Inc.
Substance NameESZOPICLONE
Active Ingredient Strength3 mg/1
DEA ScheduleCIV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68258-7049-3

30 TABLET, COATED in 1 BOTTLE (68258-7049-3)
Marketing Start Date2005-04-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68258-7049-3 [68258704903]

Lunesta TABLET, COATED
Marketing CategoryNDA
Application NumberNDA021476
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-04-04
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
ESZOPICLONE3 mg/1

OpenFDA Data

SPL SET ID:20b122fb-42ec-4fa1-9a9e-e5930e5d2e7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 540409
  • 485465
  • 540411
  • 485442
  • NDC Crossover Matching brand name "Lunesta" or generic name "Eszopiclone"

    NDCBrand NameGeneric Name
    21695-225Lunestaeszopiclone
    21695-226Lunestaeszopiclone
    68258-7048LunestaLunesta
    68258-7049LunestaLunesta
    50436-0193LunestaLunesta
    52959-919LunestaLunesta
    52959-852LunestaLunesta
    55289-014LunestaLunesta
    63402-190LunestaLunesta
    63629-3142LunestaLunesta
    63402-191LunestaLunesta
    63402-193LunestaLunesta
    80425-0115LunestaLunesta
    80425-0064LunestaLunesta
    80425-0062LunestaLunesta
    80425-0098LunestaLunesta
    80425-0066LunestaLunesta
    80425-0067LunestaLunesta
    80425-0065LunestaLunesta
    80425-0063LunestaLunesta
    0054-0290eszopicloneeszopiclone
    0054-0291eszopicloneeszopiclone
    0054-0292eszopicloneeszopiclone
    0093-5537EszopicloneEszopiclone
    0093-5538EszopicloneEszopiclone
    0093-5539EszopicloneEszopiclone
    0378-5270Eszopicloneeszopiclone
    0378-5271Eszopicloneeszopiclone
    0378-5272Eszopicloneeszopiclone
    33342-299EszopicloneEszopiclone
    33342-300EszopicloneEszopiclone
    33342-301EszopicloneEszopiclone

    Trademark Results [Lunesta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LUNESTA
    LUNESTA
    87485715 5350718 Live/Registered
    Sunovion Pharmaceuticals Inc.
    2017-06-12
    LUNESTA
    LUNESTA
    87485707 5350716 Live/Registered
    Sunovion Pharmaceuticals Inc.
    2017-06-12
    LUNESTA
    LUNESTA
    86008303 not registered Dead/Abandoned
    Sunovion Pharmaceuticals Inc.
    2013-07-11
    LUNESTA
    LUNESTA
    86008301 not registered Dead/Abandoned
    Sunovion Pharmaceuticals Inc.
    2013-07-11
    LUNESTA
    LUNESTA
    86008297 not registered Dead/Abandoned
    Sunovion Pharmaceuticals Inc.
    2013-07-11
    LUNESTA
    LUNESTA
    86008294 not registered Dead/Abandoned
    Sunovion Pharmaceuticals Inc.
    2013-07-11
    LUNESTA
    LUNESTA
    86008291 not registered Dead/Abandoned
    Sunovion Pharmaceuticals Inc.
    2013-07-11
    LUNESTA
    LUNESTA
    78867687 3839400 Dead/Cancelled
    SUNOVION PHARMACEUTICALS INC.
    2006-04-24
    LUNESTA
    LUNESTA
    78867683 3745483 Dead/Cancelled
    SUNOVION PHARMACEUTICALS INC.
    2006-04-24
    LUNESTA
    LUNESTA
    78867679 3187447 Live/Registered
    SUNOVION PHARMACEUTICALS INC.
    2006-04-24
    LUNESTA
    LUNESTA
    78315120 3133744 Live/Registered
    SUNOVION PHARMACEUTICALS INC.
    2003-10-17
    LUNESTA
    LUNESTA
    77873063 not registered Dead/Abandoned
    Comfort Revolution, LLC
    2009-11-16

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.