59011-255 : Intermezzo 3.5 mg Sublingual Tablet


NDC59011-255
Labeler: Purdue Pharma Lp
Product Type: Human Prescription Drug
Drug Name:  Intermezzo
Dosage Form: Sublingual Tablet
Application #: NDA022328
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: zz
Shapes:  Round
Colors:  Brown
Size (mm): 9
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:

  • 59011-255-05: 5 CARTON IN 1 TRAY (59011‑255‑05) > 1 POUCH IN 1 CARTON > 1 TABLET IN 1 POUCH
  • 59011-255-30: 30 POUCH IN 1 CARTON (59011‑255‑30) > 1 TABLET IN 1 POUCH

Active Ingredients:

  • Zolpidem Tartrate

Dosage Strength:

  • 3.5 mg

Inactive Ingredients:

  • Mannitol
  • Sorbitol
  • Crospovidone
  • Silicon Dioxide
  • Sodium Carbonate
  • Sodium Bicarbonate
  • Croscarmellose Sodium
  • Sodium Stearyl Fumarate
  • Sucralose

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.
  • 59011-256 Intermezzo 1.75 mg Sublingual Tablet by Purdue Pharma Lp

NDC QR Code

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NDC 59011-255 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.