53746-617 : Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet


NDC53746-617
Labeler: Amneal Pharmaceuticals, LLC
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 Amneal Pharmaceuticals, 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:

  • 53746-617-01: 100 TABLET IN 1 BOTTLE (53746‑617‑01)
  • 53746-617-05: 500 TABLET IN 1 BOTTLE (53746‑617‑05)
  • 53746-617-10: 1000 TABLET IN 1 BOTTLE (53746‑617‑10)
  • 53746-617-30: 30 TABLET IN 1 BOTTLE (53746‑617‑30)

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
  • Povidones
  • 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.
  • 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.
  • 49349-853 Apap 325 mg / Tramadol Hydrochloride 37.5 mg Oral Tablet by Remedyrepack Inc.
  • More related products ...

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 53746-617 QR Code

< Prev: 53746-590Next: 53746-641 >

Related Discussions:

Tramadol - Acetaminophen M-O 650
light yellow oblong on the pill it says M-O 650 ## tramadol/acet 37.5 is it addictive? ## The Tablet with the O M 650 ma... 2 replies
tramadol and acetaminophen
My husband has artheritis and is taking tramadol twice a day (50mg.) his dr. said he would take one every 4 hrs but he d... 2 replies
tramadol hcl acetaminophen
red kali 083 ## WHAT IS IT USED FOR? ## This is a nonsteroidal anti-inflammatory, it contains both Acetaminophen and Tra... 2 replies
hydrocodone acetaminophen 10 325 and tramadol together
Can I take one hydrocodone acetaminophen 10 325 and one tramadol 50 mg together? One 10 325 does not help much. I do not... 7 replies
Hydrocodone Acetaminophen 5 500 Tb and Tramadol
I have Ankylosing Spondylitis. Got Cortisone shots in my lumbar region and Hydrocodone/Acetaminophen 5-500 tb and Tramad... 3 replies
Does Tramadol come in IV form? Is it dangerous? Does it contain aspirin or acetaminophen? (I have hep c and should not take those?)
I have been taking tramadol a long time. For it to work, now I take 7 at a time (my doctor doesn't know this of cour... 2 replies
can these medicines be combine with my daily meds. Tramadol 50mg tablet, and hydrocodone/acetaminophen 5-500 tablet.
Hi; I am taking highblood pressure medicine, Lisnopril-htcz 20/25mg tab and amlodipine Besylate 5mg table. I am taking a... 4 replies
Acetaminophen 300/mg Codeine 30/mg
Med. round white pill w/M on one side and #3 on the other side? what is this and what are the side effects? ## The drug ... 4 replies
acetaminophen hydrocodone liquid
My daughter had surgery on Wednesday last week and was prescribed hydrocodone/acetaminophen 7.5/325 15 ml every 4 hrs fo... 3 replies
Acetaminophen OTC vs Rx
How can you tell if acetaminophen is a rx or just otc? Is the dosage a clue? ## Based on my own research I found that Ac... 3 replies




Note: The MedsChat® 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.