Glyxambi NDC 0597-0164

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-0164Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-0164Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0597-0164-30	00597016430	30 TABLET, FILM COATED in 1 BOTTLE (0597-0164-30)Marketed from Jan 30, 2015
0597-0164-39	00597016439	30 BLISTER PACK in 1 CARTON (0597-0164-39) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 30, 2015
0597-0164-90	00597016490	90 TABLET, FILM COATED in 1 BOTTLE (0597-0164-90)Marketed from Jan 30, 2015

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Glyxambi
Generic name (nonproprietary): empagliflozin and linagliptin
Active ingredients: Empagliflozin — 25 mg/1Linagliptin — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 206073
Marketing start: Jan 30, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Dipeptidyl Peptidase 4 Inhibitors (Mechanism)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 0597-0164_16f275d5-7526-4e7a-8776-665a9a6ae37aSPL ID 16f275d5-7526-4e7a-8776-665a9a6ae37aSPL set ID ddbab689-f76c-488c-9613-4168d41dd730RxCUI 1602109, 1602115, 1602118, 1602120UNII HDC1R2M35U, 3X29ZEJ4R2
Pharmacologic class: Dipeptidyl Peptidase 4 Inhibitor; Sodium-Glucose Cotransporter 2 Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400597016430 followed by a unit qualifier and the quantity

Package 00597-0164-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 20, 2026.

Indications (excerpt from the label)

GLYXAMBI is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease [see Clinical Studies (14.2) ] . GLYXAMBI is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in ad…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 206073

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 206073
Product	Strength	Form · route	Labeler	Product NDC
Glyxambiempagliflozin and linagliptin	Empagliflozin 10 mg/1; Linagliptin 5 mg/1	Tablet, Film coatedOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0182