NDC 33261-454

zaleplon

Zaleplon

zaleplon is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Zaleplon.

Product ID33261-454_102c0c6c-be48-40e6-8299-031e8f3dc843
NDC33261-454
Product TypeHuman Prescription Drug
Proprietary Namezaleplon
Generic NameZaleplon
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2009-05-05
Marketing CategoryANDA / ANDA
Application NumberANDA078989
Labeler NameAidarex Pharmaceuticals LLC
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
Listing Certified Through2019-12-31

Packaging

NDC 33261-454-60

60 CAPSULE in 1 BOTTLE, PLASTIC (33261-454-60)
Marketing Start Date2009-05-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33261-454-14 [33261045414]

zaleplon CAPSULE
Marketing CategoryANDA
Application NumberANDA078989
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-05
Inactivation Date2020-01-31

NDC 33261-454-60 [33261045460]

zaleplon CAPSULE
Marketing CategoryANDA
Application NumberANDA078989
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-05
Inactivation Date2020-01-31

NDC 33261-454-30 [33261045430]

zaleplon CAPSULE
Marketing CategoryANDA
Application NumberANDA078989
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-05-05
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ZALEPLON10 mg/1

OpenFDA Data

SPL SET ID:423a4d98-f648-4eed-bd20-857c5a8dde5b
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.