0955-1703 : Zolpidem Tartrate 12.5 mg Extended Release Tablet


NDC: 0955-1703
Labeler: Winthrop U.S, a Business of Sanofi-aventis U.S. LLC
Product Type: Human Prescription Drug
Drug Name:  Zolpidem Tartrate
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA021774
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: ZCR
Shapes:  Round
Colors:  Blue
Size (mm): 8
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.

ZCR: (0955-1703) Zolpidem Tartrate 12.5 mg Extended Release Tablet by Winthrop U.S, a Business of Sanofi-aventis U.S. LLC
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 0955-1703-10: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (0955‑1703‑10)

Active Ingredients:

  • Zolpidem Tartrate

Dosage Strength:

  • 12.5 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Fd&c Blue No. 2
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycols
  • Potassium Bitartrate
  • Titanium Dioxide
  • Ferric Oxide Yellow

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0955-1702 Zolpidem Tartrate 6.25 mg Extended Release Tablet by Winthrop U.S, a Business of Sanofi-aventis U.S. LLC
  • 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
  • 0591-3367 Zolpidem Tartrate 10 mg Oral Tablet by Watson Laboratories
  • 0603-6468 Zolpidem Tartrate 5 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0603-6469 Zolpidem Tartrate 10 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0615-8046 Zolpidem Tartrate 5 mg Oral Tablet, Film Coated by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-8047 Zolpidem Tartrate 10 mg Oral Tablet, Film Coated by Ncs Healthcare of Ky, Inc Dba Vangard Labs
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NDC QR Code

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NDC 0955-1703 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.