0378-4152 : Tramadol Hydrochloride 100 mg Oral Tablet, Extended Release


NDC: 0378-4152
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Tramadol Hydrochloride
Dosage Form: Oral Tablet, Extended Release
Application #: ANDA205257
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: M;T1
Shapes:  Round
Colors:  White
Size (mm): 6
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.

NDC Package Codes:

  • 0378-4152-01: 100 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑4152‑01)
  • 0378-4152-05: 500 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑4152‑05)
  • 0378-4152-93: 30 TABLET, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑4152‑93)

Active Ingredients:

  • Tramadol Hydrochloride

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Ammonia
  • Ferrosoferric Oxide
  • Silicon Dioxide
  • Dibutyl Sebacate
  • Ethylcelluloses
  • Polyvinyl Alcohol
  • Povidones
  • Shellac
  • Propylene Glycol
  • Sodium Stearyl Fumarate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0378-4151 Tramadol Hydrochloride 50 mg Oral Tablet 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.
  • 0093-0058 Tramadol Hydrochloride 50 mg Oral Tablet by Teva Pharmaceuticals USA Inc
  • 0228-2714 Tramadol Hydrochloride 50 mg Oral Tablet by Actavis
  • 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
  • 10147-0903 Tramadol Hydrochloride 300 mg 24 Hr Extended Release Tablet by Patriot Pharmaceuticals, LLC
  • 10370-221 Tramadol Hydrochloride 100 mg 24 Hr Extended Release Tablet by Par Pharmaceuticals, Inc.
  • 10370-222 Tramadol Hydrochloride 200 mg 24 Hr Extended Release Tablet by Par Pharmaceuticals, Inc.
  • 10370-223 Tramadol Hydrochloride 300 mg 24 Hr Extended Release Tablet by Par Pharmaceuticals, Inc.
  • 10544-009 Tramadol Hydrochloride 50 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 10544-531 Tramadol Hydrochloride 50 mg Oral Tablet by Blenheim Pharmacal, Inc.
  • 12634-786 Tramadol Hydrochloride 50 mg Oral Tablet by Apotheca, Inc
  • 16571-716 Tramadol Hydrochloride 50 mg Oral Tablet, Film Coated by Rising Pharma Holdings, Inc.
  • More related products ...

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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.