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


NDC: 0003-4223
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: 


Appearance:


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)
  • 0003-4223-90: 1 BLISTER PACK IN 1 CARTON (0003‑4223‑90) > 7 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BLISTER PACK

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.

NDC 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.