Jentadueto XR NDC 0597-0275

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-0275Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-0275Add 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	Copy
0597-0275-33	00597027533	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-33)Marketed from May 27, 2016
0597-0275-81	00597027581	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-81)Marketed from May 27, 2016

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): Jentadueto XR
Generic name (nonproprietary): linagliptin and metformin hydrochloride
Active ingredients: Linagliptin — 5 mg/1Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208026
Marketing start: May 27, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 0597-0275_531ccbe1-c1f4-46c9-bf98-9df46dafb23cSPL ID 531ccbe1-c1f4-46c9-bf98-9df46dafb23cSPL set ID 3d02a4d4-d312-80b4-05c4-691b8f0aa7aaRxCUI 1796089, 1796091, 1796094, 1796096UNII 786Z46389E, 3X29ZEJ4R2
Pharmacologic class: Biguanide; Dipeptidyl Peptidase 4 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

N400597027533 followed by a unit qualifier and the quantity

Package 00597-0275-33. 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 Aug 19, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

JENTADUETO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Limitations of Use JENTADUETO XR is not recommended in patients with type 1 diabetes mellitus. JENTADUETO XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using JENTADUETO XR [see Warnings and Precautions (5.2) ]. JENTADUETO XR is a combination of linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic con…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 208026

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

FDA NDC Directory listings under NDA 208026
Product	Strength	Form · route	Labeler	Product NDC
Jentadueto XRlinagliptin and metformin hydrochloride	Linagliptin 2.5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0270