0003-4223 : Kombiglyze 5/1000 24 Hr Extended Release Tablet

Labeler: E.r. Squibb & Sons, L.L.C.
Product Type: Human Prescription Drug
Drug Name:  Kombiglyze XR
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA200678
Rev. Date: 


Markings: 5;1000;4223
Shapes:  Oval
Colors:  Pink
Size (mm): 23
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.

5 1000 4223: (0003-4223) Kombiglyze 5/1000 24 Hr Extended Release Tablet by E.r. Squibb & Sons, L.L.C.
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:

  • 0003-4223-11: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0003‑4223‑11)
  • 0003-4223-21: 90 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0003‑4223‑21)
  • 0003-4223-31: 500 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0003‑4223‑31)

Active Ingredients:

  • Metformin Hydrochloride
  • Saxagliptin Hydrochloride

Dosage Strength:

  • 1000 mg
  • 5 mg

Inactive Ingredients:

  • Carboxymethylcellulose Sodium
  • Hypromellose 2208 (15000 Mpa.s)
  • Magnesium Stearate

Pharmaceutical Classes:

  • Dipeptidyl Peptidase 4 Inhibitor [EPC]
  • Dipeptidyl Peptidase 4 Inhibitors [MoA]
  • Biguanide [EPC]
  • Biguanides [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 0003-4221 Kombiglyze 5/500 24 Hr Extended Release Tablet by E.r. Squibb & Sons, L.L.C.
  • 0003-4222 Kombiglyze 2.5/1000 24 Hr Extended Release Tablet by E.r. Squibb & Sons, L.L.C.


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