50268-773 : Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet


NDC50268-773
Labeler: Avpak
Product Type: Human Prescription Drug
Drug Name:  Tramadol Hydrochloride and Acetaminophen
Dosage Form: Oral Tablet
Application #: ANDA090485
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: AN;617
Shapes:  Capsule
Colors:  Brown
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.

AN 617: (65162-617) Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Avpak
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:

  • 50268-773-15: 50 TABLET IN 1 BOX, UNIT‑DOSE (50268‑773‑15)

Active Ingredients:

  • Acetaminophen
  • Tramadol Hydrochloride

Dosage Strength:

  • 325 mg
  • 37.5 mg

Inactive Ingredients:

  • Carnauba Wax
  • Crospovidone
  • Ferrosoferric Oxide
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Cellulose, Microcrystalline
  • Starch, Corn
  • Polyethylene Glycols
  • Polyvinyl Alcohol
  • Povidone
  • Sodium Starch Glycolate Type a Potato
  • Stearic Acid
  • Talc
  • Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 50268-774 Tramadol Hydrochloride and Acetaminophen Oral Tablet by Avpak
  • 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.
  • 16590-230 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Stat Rx USA LLC
  • 21695-236 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Rebel Distributors Corp
  • 33261-389 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Aidarex Pharmaceuticals LLC
  • 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
  • 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.
  • 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.
  • More related products ...

NDC QR Code

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