NDC 0037-6010

Edluar

Zolpidem Tartrate

Edluar is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Zolpidem Tartrate.

Product ID0037-6010_2ba4ee31-fd16-45e7-bedb-68770a0bc5c8
NDC0037-6010
Product TypeHuman Prescription Drug
Proprietary NameEdluar
Generic NameZolpidem Tartrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-07-24
Marketing CategoryNDA / NDA
Application NumberNDA021997
Labeler NameMeda Pharmaceuticals
Substance NameZOLPIDEM TARTRATE
Active Ingredient Strength10 mg/1
Pharm Classesgamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0037-6010-02

20 BLISTER PACK in 1 BOX, UNIT-DOSE (0037-6010-02) > 2 TABLET in 1 BLISTER PACK
Marketing Start Date2009-07-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0037-6010-30 [00037601030]

Edluar TABLET
Marketing CategoryNDA
Application NumberNDA021997
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-07-24

NDC 0037-6010-02 [00037601002]

Edluar TABLET
Marketing CategoryNDA
Application NumberNDA021997
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-24

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE10 mg/1

OpenFDA Data

SPL SET ID:a32884d0-85b5-11de-8a39-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 836641
  • 836649
  • 836645
  • 836647
  • Pharmacological Class

    • gamma-Aminobutyric Acid-ergic Agonist [EPC]
    • GABA A Agonists [MoA]
    • Pyridines [CS]
    • Central Nervous System Depression [PE]

    NDC Crossover Matching brand name "Edluar" or generic name "Zolpidem Tartrate"

    NDCBrand NameGeneric Name
    0037-6010EdluarZolpidem Tartrate
    0037-6050EdluarZolpidem Tartrate
    0024-5401Ambienzolpidem tartrate
    0024-5421Ambienzolpidem tartrate
    0024-5501Ambienzolpidem tartrate
    0024-5521Ambienzolpidem tartrate
    0054-0086Zolpidem Tartratezolpidem tartrate
    0054-0087Zolpidem Tartratezolpidem tartrate
    0093-0073Zolpidem TartrateZolpidem Tartrate
    0093-0074Zolpidem TartrateZolpidem Tartrate

    Trademark Results [Edluar]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EDLUAR
    EDLUAR
    87946702 5669354 Live/Registered
    Meda Pharmaceuticals Inc.
    2018-06-04
    EDLUAR
    EDLUAR
    77557224 4045758 Dead/Cancelled
    Meda Pharmaceuticals Inc.
    2008-08-27

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