54569-4089 : Ultram 50 mg Oral Tablet, Coated


NDC54569-4089
Labeler: A-s Medication Solutions LLC
Product Type: Human Prescription Drug
Drug Name:  Ultram
Dosage Form: Oral Tablet, Coated
Application #: NDA020281
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: ULTRAM;06;59
Shapes:  Oval
Colors:  White
Size (mm): 13
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

  • 54569-4089-0: 20 TABLET, COATED IN 1 BOTTLE (54569‑4089‑0)
  • 54569-4089-1: 30 TABLET, COATED IN 1 BOTTLE (54569‑4089‑1)
  • 54569-4089-5: 15 TABLET, COATED IN 1 BOTTLE (54569‑4089‑5)

Active Ingredients:

  • Tramadol Hydrochloride

Dosage Strength:

  • 50 mg

Inactive Ingredients:

  • Starch, Corn
  • Modified Corn Starch (1-octenyl Succinic Anhydride)
  • Hypromelloses
  • Lactose
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycols
  • Polysorbate 80
  • Sodium Starch Glycolate Type a Potato
  • Titanium Dioxide
  • Carnauba Wax

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 50090-0531 Ultram 50 mg Oral Tablet, Coated by A-s Medication Solutions LLC
  • 35356-055 24 Hr Ultram 100 mg Extended Release Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 35356-056 24 Hr Ultram 300 mg Extended Release Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 49349-845 24 Hr Ultram 100 mg Extended Release Tablet by Remedyrepack Inc.
  • 49999-022 Ultram 50 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 50458-659 Ultram 50 mg Oral Tablet by Janssen Pharmaceuticals, Inc.
  • 51655-185 Ultram 50 mg/201 Oral Tablet, Coated by Northwind Pharmaceuticals
  • 54868-3605 Ultram 50 mg Oral Tablet by Physicians Total Care, Inc.
  • 55289-650 Ultram 50 mg Oral Tablet by Pd-rx Pharmaceuticals, Inc.

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.