43063-837 : Tramadol Hydrochloride and Acetaminophen Oral Tablet, Film Coated


NDC: 43063-837
Labeler: Pd-rx Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name: Tramadol Hydrochloride and Acetaminophen
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA077184
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: 537
Shapes:  Oval
Colors:  Yellow
Size (mm): 16
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.

537: (68084-825) Tramadol Hydrochloride and Acetaminophen Oral Tablet, Film Coated by Pd-rx Pharmaceuticals, Inc.
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:

  • 43063-837-20: 20 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑837‑20)
  • 43063-837-30: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑837‑30)
  • 43063-837-60: 60 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (43063‑837‑60)

Active Ingredients:

  • Tramadol Hydrochloride
  • Acetaminophen

Dosage Strength:

  • 37.5 mg
  • 325 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Sodium Starch Glycolate Type a Potato
  • Starch, Corn
  • Magnesium Stearate
  • Povidones
  • Hypromelloses
  • Titanium Dioxide
  • Polyethylene Glycols
  • Talc
  • Ferric Oxide Yellow /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
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  • 43063-782 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Pd-rx Pharmaceuticals, Inc.
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  • 0172-6359 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Ivax Pharmaceuticals, Inc.
  • 0378-8088 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Mylan Pharmaceuticals Inc.
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  • 21695-236 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Rebel Distributors Corp
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  • 33342-202 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Macleods Pharmaceuticals Limited
  • 33358-343 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Rxchange Co.
  • 35356-660 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 35356-661 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Lake Erie Medical & Surgical Supply Dba Quality Care Products LLC
  • 42254-051 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Rebel Distributors Corp
  • 42291-832 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Avkare, Inc.
  • 42549-569 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Stat Rx USA LLC
  • 42571-119 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Micro Labs Limited
  • 45865-170 Tramadol Hydrochloride and Acetaminophen Oral Tablet, Film Coated by Medsource Pharmaceuticals
  • 45865-469 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Medsource Pharmaceuticals
  • 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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