54569-3827 : Ambien 5 mg Oral Tablet


NDC54569-3827
Labeler: A-s Medication Solutions LLC
Product Type: Human Prescription Drug
Drug Name:  Ambien
Dosage Form: Oral Tablet, Film Coated
Application #: NDA019908
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: AMB;5;5401
Shapes:  Oval
Colors:  Pink
Size (mm): 10
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:

  • 54569-3827-3: 6 TABLET, FILM COATED IN 1 BOTTLE (54569‑3827‑3)

Active Ingredients:

  • Zolpidem Tartrate

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Hypromelloses
  • Lactose
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycols
  • Titanium Dioxide
  • Fd&c Red No. 40
  • Polysorbate 80

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.
  • 54569-3828 Ambien 10 mg Oral Tablet by A-s Medication Solutions LLC
  • 54569-5760 Ambien CR 12.5 mg Extended Release Tablet by A-s Medication Solutions LLC
  • 50090-0492 Ambien 5 mg Oral Tablet, Film Coated by A-s Medication Solutions LLC
  • 50090-0493 Ambien 10 mg Oral Tablet, Film Coated by A-s Medication Solutions LLC
  • 0024-5401 Ambien 5 mg Oral Tablet by Sanofi-aventis U.S. LLC
  • 0024-5421 Ambien 10 mg Oral Tablet by Sanofi-aventis U.S. LLC
  • 0024-5501 Ambien CR 6.25 mg Extended Release Tablet by Sanofi-aventis U.S. LLC
  • 0024-5521 Ambien CR 12.5 mg Extended Release Tablet by Sanofi-aventis U.S. LLC
  • 16590-009 Ambien 5 mg Oral Tablet by Stat Rx USA LLC
  • 16590-010 Ambien 10 mg Oral Tablet by Stat Rx USA LLC
  • 16590-436 Ambien CR 12.5 mg Extended Release Tablet by Stat Rx USA LLC
  • 21695-211 Ambien 5 mg Oral Tablet by Rebel Distributors Corp.
  • 21695-212 Ambien 10 mg Oral Tablet by Rebel Distributors Corp.
  • 49999-037 Ambien 10 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 49999-763 Ambien CR 12.5 mg Extended Release Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 49999-764 Ambien CR 6.25 mg Extended Release Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 55289-205 Ambien CR 12.5 mg Extended Release Tablet by Pd-rx Pharmaceuticals, Inc.
  • 61919-803 Ambien 10 mg Oral Tablet by Direct Rx
  • 61919-948 Ambien 5 mg Oral Tablet by Direct Rx
  • 63629-1256 Ambien 10 mg Oral Tablet by Bryant Ranch Prepack

NDC QR Code

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NDC 54569-3827 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.