50090-4479 : Zolpidem Tartrate 12.5 mg Oral Tablet, Film Coated, Extended Release


NDC50090-4479
Labeler: A-s Medication Solutions
Product Type: Human Prescription Drug
Drug Name:  Zolpidem Tartrate
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA204170
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: 308
Shapes:  Round
Colors:  Yellow / 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:

  • 50090-4479-0: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (50090‑4479‑0)

Active Ingredients:

  • Zolpidem Tartrate

Dosage Strength:

  • 12.5 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Microcrystalline Cellulose
  • Ferric Oxide Yellow
  • Hypromellose, Unspecified
  • Sodium Starch Glycolate Type a Potato
  • Magnesium Stearate
  • Tartaric Acid
  • Shellac
  • Propylene Glycol
  • Butyl Alcohol
  • Ferrosoferric Oxide
  • Ammonia
  • Talc
  • Polyethylene Glycol, Unspecified
  • Polysorbate 80 /

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.
  • 50090-1851 Zolpidem Tartrate 12.5 mg Oral Tablet, Film Coated, Extended Release by A-s Medication Solutions
  • 50090-2482 Zolpidem Tartrate 12.5 mg Oral Tablet, Extended Release by A-s Medication Solutions
  • 50090-2630 Zolpidem Tartrate 10 mg Oral Tablet, Coated by A-s Medication Solutions
  • 50090-2649 Zolpidem Tartrate 5 mg Oral Tablet, Film Coated by A-s Medication Solutions
  • 50090-2895 Zolpidem Tartrate 6.25 mg Oral Tablet, Extended Release by A-s Medication Solutions
  • 50090-3878 Zolpidem Tartrate 10 mg Oral Tablet, Film Coated by A-s Medication Solutions
  • 50090-3879 Zolpidem Tartrate 5 mg Oral Tablet, Film Coated by A-s Medication Solutions
  • 50090-5095 Zolpidem Tartrate 10 mg Oral Tablet, Film Coated by A-s Medication Solutions
  • 50090-5096 Zolpidem Tartrate 5 mg Oral Tablet, Film Coated by A-s Medication Solutions
  • 50090-5803 Zolpidem Tartrate 5 mg Oral Tablet by A-s Medication Solutions
  • 50090-5804 Zolpidem Tartrate 10 mg Oral Tablet by A-s Medication Solutions
  • 50090-6070 Zolpidem Tartrate 10 mg Oral Tablet, Film Coated by A-s Medication Solutions
  • 50090-1022 Zolpidem Tartrate 5 mg Oral Tablet by A-s Medication Solutions LLC
  • 50090-1023 Zolpidem Tartrate 10 mg Oral Tablet by A-s Medication Solutions LLC
  • 50090-1222 Zolpidem Tartrate 12.5 mg Oral Tablet, Film Coated, Extended Release by A-s Medication Solutions LLC
  • 50090-1335 Zolpidem Tartrate 6.25 mg Oral Tablet, Film Coated, Extended Release by A-s Medication Solutions 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
  • 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.