NDC 68788-6850

zaleplon

Zaleplon

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

Product ID68788-6850_fceee8f7-0c9c-4f44-bef3-e359edfb21cb
NDC68788-6850
Product TypeHuman Prescription Drug
Proprietary Namezaleplon
Generic NameZaleplon
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-12-12
Marketing CategoryANDA / ANDA
Application NumberANDA078989
Labeler NamePreferred Pharmaceuticals 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]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68788-6850-3

30 CAPSULE in 1 BOTTLE, PLASTIC (68788-6850-3)
Marketing Start Date2016-12-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-6850-2 [68788685002]

zaleplon CAPSULE
Marketing CategoryANDA
Application NumberANDA078989
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-12
Marketing End Date2019-04-23

NDC 68788-6850-9 [68788685009]

zaleplon CAPSULE
Marketing CategoryANDA
Application NumberANDA078989
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-12
Marketing End Date2019-04-23

NDC 68788-6850-3 [68788685003]

zaleplon CAPSULE
Marketing CategoryANDA
Application NumberANDA078989
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-12
Marketing End Date2019-04-23

NDC 68788-6850-6 [68788685006]

zaleplon CAPSULE
Marketing CategoryANDA
Application NumberANDA078989
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-12
Marketing End Date2019-04-23

NDC 68788-6850-0 [68788685000]

zaleplon CAPSULE
Marketing CategoryANDA
Application NumberANDA078989
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-12
Marketing End Date2019-04-23

Drug Details

Active Ingredients

IngredientStrength
ZALEPLON10 mg/1

OpenFDA Data

SPL SET ID:05696de1-9b6e-4414-9cc6-e63bb5789f9b
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
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