0597-0164 : Glyxambi Oral Tablet, Film Coated


NDC: 0597-0164
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Glyxambi
Dosage Form: Oral Tablet, Film Coated
Application #: NDA206073
Rev. Date: 


Appearance:


Markings: 25;5
Shapes:  Triangle (3 sides)
Colors:  Pink
Size (mm): 8
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.

NDC Package Codes:

  • 0597-0164-07: 1 BOTTLE IN 1 CARTON (0597‑0164‑07) > 7 TABLET, FILM COATED IN 1 BOTTLE
  • 0597-0164-10: 1000 TABLET, FILM COATED IN 1 BOTTLE (0597‑0164‑10)
  • 0597-0164-30: 30 TABLET, FILM COATED IN 1 BOTTLE (0597‑0164‑30)
  • 0597-0164-39: 30 BLISTER PACK IN 1 CARTON (0597‑0164‑39) > 1 TABLET, FILM COATED IN 1 BLISTER PACK
  • 0597-0164-70: 7 BLISTER PACK IN 1 CARTON (0597‑0164‑70) > 1 TABLET, FILM COATED IN 1 BLISTER PACK
  • 0597-0164-90: 90 TABLET, FILM COATED IN 1 BOTTLE (0597‑0164‑90)

Active Ingredients:

  • Empagliflozin
  • Linagliptin

Dosage Strength:

  • 25 mg
  • 5 mg

Inactive Ingredients:

  • Mannitol
  • Copovidone
  • Crospovidone
  • Titanium Dioxide
  • Talc
  • Starch, Corn
  • Hypromelloses
  • Ferric Oxide Red
  • Polyethylene Glycols
  • Magnesium Stearate

Pharmaceutical Classes:

  • Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
  • Sodium-Glucose Transporter 2 Inhibitors [MoA]
  • Dipeptidyl Peptidase 4 Inhibitors [MoA]
  • Dipeptidyl Peptidase 4 Inhibitor [EPC]

Related Products:

Based on records with the same trade name.
  • 0597-0182 Glyxambi Oral Tablet, Film Coated by Boehringer Ingelheim Pharmaceuticals, Inc.
  • 70518-2046 Glyxambi Oral Tablet, Film Coated by Remedyrepack Inc.

NDC QR Code

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NDC 0597-0164 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.