68012-003 : 24 Hr Glumetza 1000 mg Extended Release Tablet

Labeler: Santarus, Inc.
Product Type: Human Prescription Drug
Drug Name:  Glumetza
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA021748
Rev. Date: 


Markings: M1000
Shapes:  Oval
Colors:  White
Size (mm): 20
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.

M1000: (68012-003) 24 Hr Glumetza 1000 mg Extended Release Tablet by Santarus, 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:

  • 68012-003-16: 90 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (68012‑003‑16)
  • 68012-003-97: 7 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (68012‑003‑97)

Active Ingredients:

  • Metformin Hydrochloride

Dosage Strength:

  • 1000 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Polyvinyl Alcohol
  • Crospovidone
  • Glyceryl Behenate
  • Hypromelloses
  • Talc
  • Polyethylene Glycols
  • Titanium Dioxide
  • Polysorbate 80

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 68012-002 24 Hr Glumetza 500 mg Extended Release Tablet by Santarus, Inc.
  • 68012-004 Glumetza 500 mg Oral Tablet, Film Coated, Extended Release by Santarus, Inc.
  • 13913-002 24 Hr Glumetza 500 mg Extended Release Tablet by Depomed, Inc.
  • 13913-003 24 Hr Glumetza 1000 mg Extended Release Tablet by Depomed, Inc.
  • 54868-0830 24 Hr Glumetza 500 mg Extended Release Tablet by Physicians Total Care, Inc.


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