60687-838 : Zolpidem Tartrate 5 mg Oral Tablet, Film Coated


NDC: 60687-838
Labeler: American Health Packaging
Product Type: Human Prescription Drug
Drug Name:  Zolpidem Tartrate
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA078413
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.

NDC Package Codes:

  • 60687-838-01: 100 BLISTER PACK IN 1 CARTON (60687‑838‑01) / 1 TABLET, FILM COATED IN 1 BLISTER PACK (60687‑838‑11)

Active Ingredients:

  • Zolpidem Tartrate

Dosage Strength:

  • 5 mg

Pharmaceutical Classes:

  • Central Nervous System Depression [PE]
  • GABA A Receptor Positive Modulators [MoA]
  • gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]

Related Products:

Based on records with the same trade name.
  • 68084-189 Zolpidem Tartrate 5 mg/1 Oral Tablet, Coated by American Health Packaging
  • 68084-200 Zolpidem Tartrate 10 mg/1 Oral Tablet, Coated by American Health Packaging
  • 68084-225 Zolpidem Tartrate 5 mg Oral Tablet by American Health Packaging
  • 68084-226 Zolpidem Tartrate 10 mg Oral Tablet by American Health Packaging
  • 68084-523 Zolpidem Tartrate 12.5 mg Extended Release Tablet by American Health Packaging
  • 68084-889 Zolpidem Tartrate 6.25 mg Oral Tablet, Film Coated, Extended Release by American Health Packaging
  • 0054-0086 Zolpidem Tartrate 5 mg Oral Tablet by Roxane Laboratories, Inc
  • 0054-0087 Zolpidem Tartrate 10 mg Oral Tablet by Roxane Laboratories, Inc
  • 0093-0073 Zolpidem Tartrate 5 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0093-0074 Zolpidem Tartrate 10 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0179-0184 Zolpidem Tartrate 5 mg Oral Tablet, Film Coated by Kaiser Foundation Hospitals
  • 0179-1980 Zolpidem Tartrate 5 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0179-1981 Zolpidem Tartrate 10 mg Oral Tablet by Kaiser Foundation Hospitals
  • 0228-3481 Zolpidem Tartrate 6.25 mg Extended Release Tablet by Actavis Elizabeth LLC
  • 0228-3482 Zolpidem Tartrate 12.5 mg Extended Release Tablet by Actavis Elizabeth LLC
  • 0378-5305 Zolpidem Tartrate 5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-5310 Zolpidem Tartrate 10 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0591-2281 Zolpidem Tartrate 6.25 mg Extended Release Tablet by Watson Laboratories, Inc.
  • 0591-2282 Zolpidem Tartrate 12.5 mg Extended Release Tablet by Watson Laboratories, Inc.
  • 0591-3366 Zolpidem Tartrate 5 mg Oral Tablet by Watson Laboratories
  • More related products ...

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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.