0310-6135 : Kombiglyze Oral Tablet, Film Coated, Extended Release


NDC: 0310-6135
Labeler: Astrazeneca Pharmaceuticals Lp
Product Type: Human Prescription Drug
Drug Name:  Kombiglyze XR
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: NDA200678
Rev. Date: 


Appearance:


Markings: 5;500;4221
Shapes:  Oval
Colors:  Brown
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.

5 500 4221: (0310-6135) Kombiglyze Oral Tablet, Film Coated, Extended Release by Astrazeneca Pharmaceuticals Lp
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:

  • 0310-6135-30: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0310‑6135‑30)
  • 0310-6135-95: 1 BLISTER PACK IN 1 CARTON (0310‑6135‑95) > 7 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BLISTER PACK

Active Ingredients:

  • Saxagliptin Hydrochloride
  • Metformin Hydrochloride

Dosage Strength:

  • 5 mg
  • 500 mg

Inactive Ingredients:

  • Carboxymethylcellulose Sodium
  • Hypromellose 2208 (15000 Mpa.s)
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Hypromellose 2910 (15 Mpa.s)

Pharmaceutical Classes:

  • Dipeptidyl Peptidase 4 Inhibitor [EPC]
  • Dipeptidyl Peptidase 4 Inhibitors [MoA]
  • Biguanide [EPC]
  • Biguanides [CS]

Related Products:

Based on records with the same trade name.
  • 0310-6125 Kombiglyze Oral Tablet, Film Coated, Extended Release by Astrazeneca Pharmaceuticals Lp
  • 0310-6145 Kombiglyze Oral Tablet, Film Coated, Extended Release by Astrazeneca Pharmaceuticals Lp

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 0310-6135 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.