68788-8971 : Zolpidem Tartrate 10 mg Oral Tablet, Film Coated


NDC: 68788-8971
Labeler: Preferred Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Zolpidem Tartrate
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA076410
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: TEVA;74
Shapes:  Round
Colors:  White
Size (mm): 7
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:

  • 68788-8971-3: 30 TABLET, FILM COATED IN 1 BOTTLE (68788‑8971‑3)
  • 68788-8971-6: 60 TABLET, FILM COATED IN 1 BOTTLE (68788‑8971‑6)
  • 68788-8971-9: 90 TABLET, FILM COATED IN 1 BOTTLE (68788‑8971‑9)

Active Ingredients:

  • Zolpidem Tartrate

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Hypromellose 2910 (5 Mpa.s)
  • Hypromellose 2910 (3 Mpa.s)
  • Hypromellose 2910 (6 Mpa.s)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycol 400
  • Polysorbate 80
  • Sodium Starch Glycolate Type a Potato
  • Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 68788-7182 Zolpidem Tartrate 12.5 mg Oral Tablet, Film Coated, Extended Release by Preferred Pharmaceuticals Inc.
  • 68788-7407 Zolpidem Tartrate 6.25 mg Oral Tablet, Film Coated, Extended Release by Preferred Pharmaceuticals Inc.
  • 68788-7903 Zolpidem Tartrate 6.25 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals Inc.
  • 68788-8118 Zolpidem Tartrate 6.25 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals Inc.
  • 68788-8376 Zolpidem Tartrate 12.5 mg Oral Tablet, Film Coated, Extended Release by Preferred Pharmaceuticals Inc.
  • 68788-8654 Zolpidem Tartrate 6.25 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals Inc.
  • 68788-8970 Zolpidem Tartrate 5 mg Oral Tablet, Film Coated by Preferred Pharmaceuticals Inc.
  • 68788-7422 Zolpidem Tartrate 12.5 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals, Inc..
  • 68788-7688 Zolpidem Tartrate 6.25 mg Oral Tablet, Extended Release by Preferred Pharmaceuticals, Inc.
  • 68788-7773 Zolpidem Tartrate 12.5 mg Oral Tablet, Film Coated, Extended Release by Preferred Pharmaceuticals, Inc.
  • 68788-9126 Zolpidem Tartrate 5 mg Oral Tablet by Preferred Pharmaceuticals, Inc
  • 68788-9127 Zolpidem Tartrate 10 mg Oral Tablet by Preferred Pharmaceuticals, Inc
  • 68788-9278 Zolpidem Tartrate 5 mg Oral Tablet, Film Coated by Preferred Pharmaceuticals, Inc.
  • 68788-9282 Zolpidem Tartrate 5 mg Oral Tablet, Film Coated by Preferred Pharmaceuticals, Inc.
  • 68788-9904 Zolpidem Tartrate 5 mg Oral Tablet by Preferred Pharmaceuticals, Inc.
  • 68788-9905 Zolpidem Tartrate 10 mg Oral Tablet by Preferred Pharmaceuticals, Inc.
  • 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
  • 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.