Jentadueto NDC 0597-0146

NDC codes

FDA NDC Directory

Product NDC (as listed)0597-0146Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00597-0146Add 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
0597-0146-18	00597014618	180 TABLET, FILM COATED in 1 BOTTLE (0597-0146-18)Marketed from Feb 13, 2012
0597-0146-60	00597014660	60 TABLET, FILM COATED in 1 BOTTLE (0597-0146-60)Marketed from Feb 13, 2012

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
Generic name (nonproprietary): linagliptin and metformin hydrochloride
Active ingredients: Linagliptin — 2.5 mg/1Metformin hydrochloride — 500 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 201281
Marketing start: Feb 13, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
Identifiers: Product ID 0597-0146_4183cb57-05f5-40af-809f-201458e670d5SPL ID 4183cb57-05f5-40af-809f-201458e670d5SPL set ID f6dd9b86-0d18-95d4-2bc7-05591bfdd597RxCUI 1243020, 1243026, 1243027, 1243033, 1243034, 1243040UNII 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

N400597014618 followed by a unit qualifier and the quantity

Package 00597-0146-18. 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 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Limitations of Use JENTADUETO is not recommended in patients with type 1 diabetes mellitus. JENTADUETO 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 [see Warnings and Precautions (5.2) ]. JENTADUETO 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 control in adults …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 201281

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

FDA NDC Directory listings under NDA 201281
Product	Strength	Form · route	Labeler	Product NDC
Jentaduetolinagliptin and metformin hydrochloride	Linagliptin 2.5 mg/1; Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0147
Jentaduetolinagliptin and metformin hydrochloride	Linagliptin 2.5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0148