NDC 0037-6050

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 ID0037-6050_2ba4ee31-fd16-45e7-bedb-68770a0bc5c8
NDC0037-6050
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 Strength5 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 0037-6050-30

3 BLISTER PACK in 1 CARTON (0037-6050-30) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2009-07-24
Marketing End Date2023-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0037-6050-30 [00037605030]

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

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE5 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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