NDC 52959-957

ZALEPLON

Zaleplon

ZALEPLON is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Zaleplon.

Product ID52959-957_f99f26bc-5e6c-4b5a-9657-6bc3861fa5e5
NDC52959-957
Product TypeHuman Prescription Drug
Proprietary NameZALEPLON
Generic NameZaleplon
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2010-12-15
Marketing CategoryANDA / ANDA
Application NumberANDA078989
Labeler NameH.J. Harkins Company, 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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52959-957-60

60 CAPSULE in 1 BOTTLE (52959-957-60)
Marketing Start Date2010-12-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-957-30 [52959095730]

ZALEPLON CAPSULE
Marketing CategoryANDA
Application NumberANDA078989
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-12-15
Inactivation Date2019-10-29

NDC 52959-957-60 [52959095760]

ZALEPLON CAPSULE
Marketing CategoryANDA
Application NumberANDA078989
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-12-15
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
ZALEPLON10 mg/1

OpenFDA Data

SPL SET ID:4ccb8d3d-31ef-49ff-8567-c620b9d74f8c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.