NDC 0093-5269

Zaleplon

Zaleplon

Zaleplon is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Zaleplon.

Product ID0093-5269_34b1199c-f8d1-4ba1-b0c2-7954b5248a4c
NDC0093-5269
Product TypeHuman Prescription Drug
Proprietary NameZaleplon
Generic NameZaleplon
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2008-06-06
Marketing End Date2020-02-29
Marketing CategoryANDA / ANDA
Application NumberANDA077239
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameZALEPLON
Active Ingredient Strength10 mg/1
Pharm Classesgamma-Aminobutyric Acid A Receptor Agonist [EPC],GABA A Agonists [MoA],Central Nervous System Depression [PE]
DEA ScheduleCIV
NDC Exclude FlagN

Packaging

NDC 0093-5269-01

100 CAPSULE in 1 BOTTLE (0093-5269-01)
Marketing Start Date2008-06-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-5269-10 [00093526910]

Zaleplon CAPSULE
Marketing CategoryANDA
Application NumberANDA077239
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-06-06
Marketing End Date2010-11-12

NDC 0093-5269-01 [00093526901]

Zaleplon CAPSULE
Marketing CategoryANDA
Application NumberANDA077239
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-06-06
Marketing End Date2020-02-29

NDC 0093-5269-56 [00093526956]

Zaleplon CAPSULE
Marketing CategoryANDA
Application NumberANDA077239
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-06-06
Marketing End Date2010-11-12

Drug Details

Active Ingredients

IngredientStrength
ZALEPLON10 mg/1

OpenFDA Data

SPL SET ID:71be4cb7-a42f-43be-9b9b-f090edb2fd21
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313762
  • 313761

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Zaleplon" or generic name "Zaleplon"

    NDCBrand NameGeneric Name
    0054-0084ZaleplonZaleplon
    0054-0085ZaleplonZaleplon
    0093-5268ZaleplonZaleplon
    0093-5269ZaleplonZaleplon
    21695-105ZALEPLONZALEPLON
    21695-376ZALEPLONZALEPLON
    29300-131zaleplonzaleplon
    29300-132zaleplonzaleplon
    33261-454zaleplonzaleplon
    33261-486zaleplonzaleplon
    35356-656zaleplonzaleplon
    42043-210ZaleplonZaleplon
    42043-211ZaleplonZaleplon
    42254-130zaleplonzaleplon
    42254-147zaleplonzaleplon
    42254-189zaleplonzaleplon
    43063-505ZALEPLONZALEPLON
    43063-783zaleplonzaleplon
    43063-912ZaleplonZaleplon
    67877-210ZALEPLONZALEPLON
    67877-211ZALEPLONZALEPLON
    68788-6850zaleplonzaleplon
    68788-7208zaleplonzaleplon
    71335-0236zaleplonzaleplon
    71335-1054ZALEPLONZALEPLON
    45865-541zaleplonzaleplon
    50090-1564zaleplonzaleplon
    50090-3420ZaleplonZaleplon
    50436-1006ZaleplonZaleplon
    52959-957ZALEPLONZALEPLON
    55700-190ZaleplonZaleplon
    57237-239ZALEPLONZALEPLON
    57237-240ZALEPLONZALEPLON
    61919-629ZALEPLONZALEPLON
    63629-3405zaleplonzaleplon
    65862-214ZALEPLONZALEPLON
    65862-215ZALEPLONZALEPLON
    66336-056ZaleplonZaleplon
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