54868-5558 : 24 Hr Fortamet 500 mg Extended Release Tablet


NDC: 54868-5558
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Fortamet
Dosage Form: Oral Tablet, Extended Release
Application #: NDA021574
Rev. Date: 


Appearance:


Markings: 574
Shapes:  Round
Colors:  White
Size (mm): 12
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.

574: (59630-574) 24 Hr Fortamet 500 mg Extended Release Tablet by Physicians Total Care, 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:

  • 54868-5558-0: 60 TABLET, EXTENDED RELEASE IN 1 BOTTLE (54868‑5558‑0)
  • 54868-5558-1: 90 TABLET, EXTENDED RELEASE IN 1 BOTTLE (54868‑5558‑1)

Active Ingredients:

  • Metformin Hydrochloride

Dosage Strength:

  • 500 mg

Inactive Ingredients:

  • Candelilla Wax
  • Cellulose Acetate
  • Hypromellose
  • Magnesium Stearate
  • Polyethylene Glycol
  • Polysorbate 80
  • Povidone
  • Sodium Lauryl Sulfate
  • Ferrosoferric Oxide
  • Titanium Dioxide
  • Triacetin

Pharmaceutical Classes:

  • Biguanide [EPC]
  • Biguanides [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 54868-2894 24 Hr Fortamet 1000 mg Extended Release Tablet by Physicians Total Care, Inc.
  • 59630-574 24 Hr Fortamet 500 mg Extended Release Tablet by Shionogi Inc.
  • 59630-575 24 Hr Fortamet 1000 mg Extended Release Tablet by Shionogi Inc.

NDC QR Code

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NDC 54868-5558 QR Code

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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.