NDC 67544-996

Zolpidem Tartrate

Zolpidem Tartrate

Zolpidem Tartrate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Zolpidem Tartrate.

Product ID67544-996_50878745-f6d3-4a5c-ba86-83814855db5b
NDC67544-996
Product TypeHuman Prescription Drug
Proprietary NameZolpidem Tartrate
Generic NameZolpidem Tartrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-04-23
Marketing CategoryANDA / ANDA
Application NumberANDA076578
Labeler NameAphena Pharma Solutions - Tennessee, LLC
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 67544-996-53

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-996-53)
Marketing Start Date2008-01-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67544-996-62 [67544099662]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-05-05
Marketing End Date2019-12-31

NDC 67544-996-15 [67544099615]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-03-03
Marketing End Date2019-12-31

NDC 67544-996-30 [67544099630]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-05
Marketing End Date2019-12-31

NDC 67544-996-59 [67544099659]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-03-10
Marketing End Date2019-12-31

NDC 67544-996-10 [67544099610]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-18
Marketing End Date2019-12-31

NDC 67544-996-25 [67544099625]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-20
Marketing End Date2019-12-31

NDC 67544-996-60 [67544099660]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-30
Marketing End Date2019-12-31

NDC 67544-996-21 [67544099621]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-09-25
Marketing End Date2019-12-31

NDC 67544-996-28 [67544099628]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-10-02
Marketing End Date2019-12-31

NDC 67544-996-45 [67544099645]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-10-02
Marketing End Date2019-12-31

NDC 67544-996-14 [67544099614]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-10-02
Marketing End Date2019-12-31

NDC 67544-996-53 [67544099653]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-05
Marketing End Date2019-12-31

NDC 67544-996-20 [67544099620]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-01-11
Marketing End Date2019-12-31

NDC 67544-996-07 [67544099607]

Zolpidem Tartrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076578
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-30
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE10 mg/1

OpenFDA Data

SPL SET ID:0a79602e-7790-4c0e-8f38-9c3672de4be3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854873

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0054-0086Zolpidem Tartratezolpidem tartrate
    0054-0087Zolpidem Tartratezolpidem tartrate
    0093-0073Zolpidem TartrateZolpidem Tartrate
    0093-0074Zolpidem TartrateZolpidem Tartrate
    67544-996Zolpidem TartrateZolpidem Tartrate
    68071-1895ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
    68071-1997Zolpidem TartrateZolpidem Tartrate
    68071-1887ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
    68071-4089Zolpidem TartrateZolpidem Tartrate
    68071-4598ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
    68084-523Zolpidem TartrateZolpidem Tartrate
    68084-189Zolpidem TartrateZolpidem Tartrate
    68180-779ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
    68180-780ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
    68788-7182Zolpidem TartrateZolpidem Tartrate
    68788-7407Zolpidem TartrateZolpidem Tartrate
    68788-9126ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
    68788-9282Zolpidem TartrateZolpidem Tartrate
    68788-9278Zolpidem TartrateZolpidem Tartrate
    68788-8971Zolpidem TartrateZolpidem Tartrate
    68788-9127ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
    68788-8970Zolpidem TartrateZolpidem Tartrate
    70518-0161Zolpidem TartrateZolpidem Tartrate
    70518-1663Zolpidem TartrateZolpidem Tartrate
    71335-0079Zolpidem TartrateZolpidem Tartrate
    71335-0154ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
    71335-0283Zolpidem TartrateZolpidem Tartrate
    71335-0134Zolpidem TartrateZolpidem Tartrate
    71610-151Zolpidem TartrateZolpidem Tartrate
    71610-192Zolpidem TartrateZolpidem Tartrate
    71610-152Zolpidem TartrateZolpidem Tartrate
    71610-156Zolpidem TartrateZolpidem Tartrate
    75921-469Zolpidem TartrateZolpidem Tartrate
    0615-8047Zolpidem TartrateZolpidem Tartrate
    0615-8046Zolpidem TartrateZolpidem Tartrate
    0615-8226Zolpidem TartrateZolpidem Tartrate
    0615-8225Zolpidem TartrateZolpidem Tartrate
    0781-5315Zolpidem tartrateZolpidem tartrate
    0781-5316Zolpidem tartrateZolpidem tartrate
    0781-5318Zolpidem TartrateZolpidem Tartrate
    0781-5317Zolpidem TartrateZolpidem Tartrate
    0904-6082ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
    0904-6083ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
    0955-1703Zolpidem TartrateZolpidem Tartrate
    10544-539Zolpidem TartrateZolpidem Tartrate
    0955-1702Zolpidem TartrateZolpidem Tartrate
    10544-040ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
    10544-548Zolpidem TartrateZolpidem Tartrate
    10544-540Zolpidem TartrateZolpidem Tartrate
    12634-944ZOLPIDEM TARTRATEZOLPIDEM TARTRATE
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