54569-5308 : Ultracet Oral Tablet, Coated


NDC: 54569-5308
Labeler: A-s Medication Solutions LLC
Product Type: Human Prescription Drug
Drug Name:  Ultracet
Dosage Form: Oral Tablet, Coated
Application #: NDA021123
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: O;M;650
Shapes:  Oval
Colors:  Yellow
Size (mm): 15
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.

O M 650: (50458-650) Ultracet Oral Tablet, Coated by A-s Medication Solutions LLC
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 54569-5308-0: 20 TABLET, COATED IN 1 BOTTLE (54569‑5308‑0)
  • 54569-5308-1: 30 TABLET, COATED IN 1 BOTTLE (54569‑5308‑1)

Active Ingredients:

  • Acetaminophen
  • Tramadol Hydrochloride

Dosage Strength:

  • 325 mg
  • 37.5 mg

Inactive Ingredients:

  • Powdered Cellulose
  • Sodium Starch Glycolate Type a Potato
  • Starch, Corn
  • Magnesium Stearate
  • Hypromelloses
  • Polyethylene Glycols
  • Polysorbate 80
  • Titanium Dioxide
  • Ferrosoferric Oxide
  • Carnauba Wax

Pharmaceutical Classes:

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 50090-0748 Ultracet Oral Tablet, Coated by A-s Medication Solutions LLC
  • 21695-143 Ultracet (Apap 325 mg / Tramadol Hydrochloride 37.5 mg) Oral Tablet by Rebel Distributors Corp
  • 49999-118 Ultracet (Apap 325 mg / Tramadol Hydrochloride 37.5 mg) Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 50458-650 Ultracet (Apap 325 mg / Tramadol Hydrochloride 37.5 mg) Oral Tablet by Janssen Pharmaceuticals, Inc.
  • 54868-4703 Ultracet (Apap 325 mg / Tramadol Hydrochloride 37.5 mg) Oral Tablet by Physicians Total Care, Inc.
  • 55289-617 Ultracet (Apap 325 mg / Tramadol Hydrochloride 37.5 mg) Oral Tablet by Pd-rx Pharmaceuticals, Inc.

NDC QR Code

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NDC 54569-5308 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.