Prescription drug · NDA
Jentadueto XR (Linagliptin and metformin hydrochloride) NDC 0597-0275
Linagliptin 5 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated, Extended release · Oral · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-0275-33 | 0059702753300597027533 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0597-0275-33)Marketed from May 27, 2016 | |
| 0597-0275-81 | 0059702758100597027581 | 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.NDC labeler code 0597
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208026
- Marketing start
- Listing expires
- 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
N400597027533followed by a unit qualifier and the quantityPackage 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 . 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.
About NDC 0597-0275
- What is NDC 0597-0275?
- 0597-0275 is the product NDC for Jentadueto XR, Linagliptin 5 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, extended release, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jentadueto XR (Linagliptin and metformin hydrochloride).
- What is the active ingredient?
- Linagliptin, Metformin hydrochloride.
- Who is the labeler?
- Boehringer Ingelheim Pharmaceuticals, Inc., NDC labeler code 0597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jentadueto XR?
- 1 other product NDC are listed under this name. See all Jentadueto XR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Jentadueto XR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 | 00597-0270-7300597-0270-94 |
Other NDCs under NDA 208026
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 |