54868-5908 : Zaleplon 10 mg Oral Capsule


NDC: 54868-5908
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Zaleplon
Dosage Form: Oral Capsule
Application #: ANDA078829
Rev. Date: 
CSA Schedule: CIV (US) [1]


[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: E20;10;mg
Shapes:  Capsule
Colors:  Green
Size (mm): 14
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 54868-5908-0: 10 CAPSULE IN 1 BOTTLE (54868‑5908‑0)
  • 54868-5908-1: 30 CAPSULE IN 1 BOTTLE (54868‑5908‑1)

Active Ingredients:

  • Zaleplon

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Lactose Monohydrate
  • Starch, Corn
  • Sodium Lauryl Sulfate
  • Silicon Dioxide
  • Stearic Acid
  • Fd&c Blue No. 1
  • Fd&c Green No. 3
  • Fd&c Yellow No. 5
  • Titanium Dioxide
  • Gelatin
  • Ferrosoferric Oxide
  • Shellac

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 54868-5909 Zaleplon 5 mg Oral Capsule by Physicians Total Care, Inc.
  • 0054-0084 Zaleplon 5 mg Oral Capsule by Roxane Laboratories, Inc
  • 0054-0085 Zaleplon 10 mg Oral Capsule by Roxane Laboratories, Inc
  • 0093-5268 Zaleplon 5 mg Oral Capsule by Teva Pharmaceuticals USA Inc
  • 0093-5269 Zaleplon 10 mg Oral Capsule by Teva Pharmaceuticals USA Inc
  • 0378-6805 Zaleplon 5 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-6810 Zaleplon 10 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0832-0400 Zaleplon 5 mg Oral Capsule by Upsher-smith Laboratories, Inc.
  • 0832-0401 Zaleplon 10 mg Oral Capsule by Upsher-smith Laboratories, Inc.
  • 16714-551 Zaleplon 5 mg Oral Capsule by Northstar Rx LLC
  • 16714-561 Zaleplon 10 mg Oral Capsule by Northstar Rx LLC
  • 21695-105 Zaleplon 10 mg Oral Capsule by Rebel Distributors Corp.
  • 21695-376 Zaleplon 5 mg Oral Capsule by Rebel Distributors Corp.
  • 29300-131 Zaleplon 5 mg Oral Capsule by Unichem Pharmaceuticals (Usa), Inc.
  • 29300-132 Zaleplon 10 mg Oral Capsule by Unichem Pharmaceuticals (Usa), Inc.
  • 33261-454 Zaleplon 10 mg/1 Oral Capsule by Aidarex Pharmaceuticals LLC
  • 33261-486 Zaleplon 5 mg/1 Oral Capsule by Aidarex Pharmaceuticals LLC
  • 35356-573 Zaleplon 10 mg Oral Capsule by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 35356-656 Zaleplon 10 mg Oral Capsule by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 42043-210 Zaleplon 5 mg Oral Capsule by Orchidpharma Inc
  • More related products ...

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.