60429-515 : Zolpidem Tartrate Extended-release 12.5 mg Oral Tablet, Film Coated, Extended Release


NDC60429-515
Labeler: Golden State Medical Supply, Inc.
Product Type: Human Prescription Drug
Drug Name:  Zolpidem Tartrate Extended-release
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA078148
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: A116
Shapes:  Round
Colors:  White
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.

NDC Package Codes:

  • 60429-515-01: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (60429‑515‑01)

Active Ingredients:

  • Zolpidem Tartrate

Dosage Strength:

  • 12.5 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Hypromelloses
  • Magnesium Stearate
  • Polyethylene Glycols
  • Sucrose
  • Titanium Dioxide
  • Polydextrose
  • Triacetin

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.
  • 60429-514 Zolpidem Tartrate Extended-release 6.25 mg Oral Tablet, Film Coated, Extended Release by Golden State Medical Supply, Inc.
  • 50090-3994 Zolpidem Tartrate Extended-release 6.25 mg Oral Tablet, Film Coated, Extended Release by A-s Medication Solutions
  • 50436-0116 Zolpidem Tartrate Extended-release 12.5 mg Oral Tablet, Film Coated, Extended Release by Unit Dose Services
  • 51407-554 Zolpidem Tartrate Extended-release 6.25 mg Oral Tablet, Film Coated, Extended Release by Golden State Medical Supply
  • 51407-555 Zolpidem Tartrate Extended-release 12.5 mg Oral Tablet, Film Coated, Extended Release by Golden State Medical Supply
  • 55700-777 Zolpidem Tartrate Extended-release 6.25 mg Oral Tablet, Film Coated, Extended Release by Quality Care Products, LLC
  • 60760-116 Zolpidem Tartrate 12.5 mg Extended Release Tablet by St Marys Medical Park Pharmacy
  • 69189-0116 Zolpidem Tartrate Extended-release 12.5 mg Oral Tablet, Film Coated, Extended Release by Avera Mckennan Hospital
  • 69189-0117 Zolpidem Tartrate Extended-release 6.25 mg Oral Tablet, Film Coated, Extended Release by Avera Mckennan Hospital
  • 71335-1801 Zolpidem Tartrate Extended-release 6.25 mg Oral Tablet, Film Coated, Extended Release by Bryant Ranch Prepack
  • 71610-564 Zolpidem Tartrate Extended-release 12.5 mg Oral Tablet, Film Coated, Extended Release by Aphena Pharma Solutions - Tennessee, LLC

NDC QR Code

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NDC 60429-515 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.