59630-574 : 24 Hr Fortamet 500 mg Extended Release Tablet

Labeler: Shionogi Inc.
Product Type: Human Prescription Drug
Drug Name:  Fortamet
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA021574
Rev. Date: 


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 Shionogi 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:

  • 59630-574-60: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (59630‑574‑60)

Active Ingredients:

  • Metformin Hydrochloride

Dosage Strength:

  • 500 mg

Inactive Ingredients:

  • Candelilla Wax
  • Cellulose Acetate
  • Ferrosoferric Oxide
  • Hypromellose 2910 (3 Mpa.s)
  • Hypromellose 2910 (6 Mpa.s)
  • Magnesium Stearate
  • Polyethylene Glycol 400
  • Polyethylene Glycol 8000
  • Polysorbate 80
  • Povidones
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Triacetin

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 59630-575 24 Hr Fortamet 1000 mg Extended Release Tablet by Shionogi Inc.
  • 54868-2894 24 Hr Fortamet 1000 mg Extended Release Tablet by Physicians Total Care, Inc.
  • 54868-5558 24 Hr Fortamet 500 mg Extended Release Tablet by Physicians Total Care, Inc.


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NDC 59630-574 QR Code

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