71610-564 : Zolpidem Tartrate Extended-release 12.5 mg Oral Tablet, Film Coated, Extended Release


NDC71610-564
Labeler: Aphena Pharma Solutions - Tennessee, LLC
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.

NDC Package Codes:

  • 71610-564-30: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (71610‑564‑30)

Active Ingredients:

  • Zolpidem Tartrate

Dosage Strength:

  • 12.5 mg

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 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
  • 60429-514 Zolpidem Tartrate Extended-release 6.25 mg Oral Tablet, Film Coated, Extended Release by Golden State Medical Supply, Inc.
  • 60429-515 Zolpidem Tartrate Extended-release 12.5 mg Oral Tablet, Film Coated, Extended Release by Golden State Medical Supply, Inc.
  • 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

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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.