NDC 68180-780

ZOLPIDEM TARTRATE

Zolpidem Tartrate

ZOLPIDEM TARTRATE is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Zolpidem Tartrate.

Product ID68180-780_7d3a7138-59fd-4edd-b2eb-81f1753460a1
NDC68180-780
Product TypeHuman Prescription Drug
Proprietary NameZOLPIDEM TARTRATE
Generic NameZolpidem Tartrate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-04-11
Marketing CategoryANDA / ANDA
Application NumberANDA078970
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameZOLPIDEM TARTRATE
Active Ingredient Strength13 mg/1
Pharm ClassesCentral Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68180-780-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-780-01)
Marketing Start Date2014-04-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68180-780-01 [68180078001]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-11

NDC 68180-780-06 [68180078006]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-11

NDC 68180-780-03 [68180078003]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-11

NDC 68180-780-02 [68180078002]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-11

NDC 68180-780-11 [68180078011]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-11

NDC 68180-780-13 [68180078013]

ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-11

Drug Details

Active Ingredients

IngredientStrength
ZOLPIDEM TARTRATE12.5 mg/1

OpenFDA Data

SPL SET ID:ac647afe-2fe5-4056-806f-abdd54789b45
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854894
  • 854880

    • Pharmacological Class

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

    Medicade Reported Pricing

    68180078001 ZOLPIDEM TART ER 12.5 MG TAB

    Pricing Unit: EA | Drug Type:

    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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