35356-661 : Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet


NDC: 35356-661
Labeler: Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
Product Type: Human Prescription Drug
Drug Name:  Tramadol Hydrochloride and Acetaminophen
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: (0172-6359) Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products 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:

  • 35356-661-00: 100 TABLET, COATED IN 1 BOTTLE (35356‑661‑00)
  • 35356-661-30: 30 TABLET, COATED IN 1 BOTTLE (35356‑661‑30)
  • 35356-661-60: 60 TABLET, COATED IN 1 BOTTLE (35356‑661‑60)
  • 35356-661-90: 90 TABLET, COATED IN 1 BOTTLE (35356‑661‑90)

Active Ingredients:

  • Acetaminophen
  • Tramadol Hydrochloride

Dosage Strength:

  • 325 mg
  • 37.5 mg

Inactive Ingredients:

  • Powdered Cellulose
  • Starch, Corn
  • Sodium Starch Glycolate Type a Potato
  • 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.
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  • 49999-693 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
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  • 43063-599 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-782 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
  • 43063-837 Tramadol Hydrochloride and Acetaminophen Oral Tablet, Film Coated by Pd-rx Pharmaceuticals, Inc.
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  • 47781-219 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Alvogen, Inc.
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NDC QR Code

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