43353-072 : Tramadol Hydrochloride 50 mg Oral Tablet, Coated


NDC: 43353-072
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product Type: Human Prescription Drug
Drug Name:  Tramadol Hydrochloride
Dosage Form: Oral Tablet, Coated
Application #: ANDA076003
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;627
Shapes:  Round
Colors:  White
Size (mm): 9
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 627: (43353-072) Tramadol Hydrochloride 50 mg Oral Tablet, Coated by Aphena Pharma Solutions - Tennessee, 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:

  • 43353-072-15: 15 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑15)
  • 43353-072-20: 20 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑20)
  • 43353-072-24: 224 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑24)
  • 43353-072-28: 28 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑28)
  • 43353-072-30: 30 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑30)
  • 43353-072-40: 40 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑40)
  • 43353-072-45: 45 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑45)
  • 43353-072-46: 56 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑46)
  • 43353-072-48: 480 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑48)
  • 43353-072-50: 50 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑50)
  • 43353-072-53: 60 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑53)
  • 43353-072-54: 84 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑54)
  • 43353-072-57: 80 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑57)
  • 43353-072-60: 90 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑60)
  • 43353-072-65: 100 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑65)
  • 43353-072-67: 168 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑67)
  • 43353-072-70: 120 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑70)
  • 43353-072-72: 112 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑72)
  • 43353-072-73: 135 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑73)
  • 43353-072-75: 150 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑75)
  • 43353-072-80: 180 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑80)
  • 43353-072-85: 200 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑85)
  • 43353-072-89: 720 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑89)
  • 43353-072-90: 240 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑90)
  • 43353-072-92: 270 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑92)
  • 43353-072-94: 360 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑94)
  • 43353-072-98: 540 TABLET, COATED IN 1 BOTTLE, PLASTIC (43353‑072‑98)

Active Ingredients:

  • Tramadol Hydrochloride

Dosage Strength:

  • 50 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Sodium Starch Glycolate Type a Potato
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycols
  • Polysorbate 80
  • Titanium Dioxide
  • Hypromelloses
  • Starch, Corn

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
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  • 71610-392 Tramadol Hydrochloride 50 mg Oral Tablet, Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 71610-398 Tramadol Hydrochloride 50 mg Oral Tablet, Film Coated by Aphena Pharma Solutions - Tennessee, LLC
  • 0093-0058 Tramadol Hydrochloride 50 mg Oral Tablet by Teva Pharmaceuticals USA Inc
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  • 0228-2714 Tramadol Hydrochloride 50 mg Oral Tablet by Actavis
  • 0378-4151 Tramadol Hydrochloride 50 mg Oral Tablet by Mylan Pharmaceuticals Inc.
  • 0378-4152 Tramadol Hydrochloride 100 mg Oral Tablet, Extended Release by Mylan Pharmaceuticals Inc.
  • 0378-4153 Tramadol Hydrochloride 200 mg Oral Tablet, Extended Release by Mylan Pharmaceuticals Inc.
  • 0378-4154 Tramadol Hydrochloride 300 mg Oral Tablet, Extended Release by Mylan Pharmaceuticals Inc.
  • 0615-7810 Tramadol Hydrochloride 50 mg Oral Tablet, Film Coated by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0615-8005 Tramadol Hydrochloride 50 mg Oral Tablet, Coated by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0904-6119 Tramadol Hydrochloride 50 mg Oral Tablet by Major Pharmaceuticals
  • 0904-6365 Tramadol Hydrochloride 50 mg/1 Oral Tablet, Film Coated by Major Pharmaceuticals
  • 0904-7179 Tramadol Hydrochloride 50 mg Oral Tablet by Major Pharmaceuticals
  • 10147-0901 Tramadol Hydrochloride 100 mg 24 Hr Extended Release Tablet by Patriot Pharmaceuticals, LLC
  • 10147-0902 Tramadol Hydrochloride 200 mg 24 Hr Extended Release Tablet by Patriot Pharmaceuticals, LLC
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  • 10370-221 Tramadol Hydrochloride 100 mg 24 Hr Extended Release Tablet by Par Pharmaceuticals, Inc.
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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.