Prescription drug · NDA
Tradjenta (Linagliptin) NDC 0597-0140
Linagliptin 5 mg/1 · Tablet, Film coated · Oral · Boehringer Ingelheim Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0597-0140-30 | 00597014030 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30)Marketed from May 9, 2011 | |
| 0597-0140-61 | 00597014061 | 100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 9, 2011 | |
| 0597-0140-90 | 00597014090 | 90 TABLET, FILM COATED in 1 BOTTLE (0597-0140-90)Marketed from May 9, 2011 |
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)
- Tradjenta
- Generic name (nonproprietary)
- linagliptin
- Active ingredients
- Linagliptin — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.NDC labeler code 0597
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 201280
- Marketing start
- Listing expires
- Other FDA classes
- Dipeptidyl Peptidase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0597-0140_80d5d700-e711-462e-b291-3684a78d00b8SPL ID 80d5d700-e711-462e-b291-3684a78d00b8SPL set ID c797ea5c-cab7-494b-9044-27eba0cfe40fRxCUI 1100702, 1100706UNII 3X29ZEJ4R2
- Pharmacologic class
- 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
N400597014030followed by a unit qualifier and the quantityPackage 00597-0140-30. 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 .
Indications (excerpt from the label)
TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . TRADJENTA is 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 ( 1 ) Limitations of Use Not recommended in patients with type 1 diabetes mellitus as it would not be effective ( 1 ) Has not been studied in patients with a history of pancreatitis ( 1 ) Limitations of Use TRADJENTA is not recommended in patients with type 1 diabetes mellitus as it would not be effective. TRADJENTA has not been studied in patients with a history of pancreatitis. It is unknown whethe…
Excerpt only. Read the full label for complete information.
About NDC 0597-0140
- What is NDC 0597-0140?
- 0597-0140 is the product NDC for Tradjenta (linagliptin), Linagliptin 5 mg/1 tablet, film coated, listed with the FDA by Boehringer Ingelheim Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tradjenta (Linagliptin).
- What is the active ingredient?
- Linagliptin.
- 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 Tradjenta?
- 2 other product NDCs are listed under this name. See all Tradjenta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tradjenta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tradjentalinagliptin | Linagliptin 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4383 | 50090-4383-00 |
| Tradjentalinagliptin | Linagliptin 5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0410 | 55154-0410-08 |
Other NDCs under NDA 201280
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 |
|---|---|---|---|---|
| Tradjentalinagliptin | Linagliptin 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4383 |
| Tradjentalinagliptin | Linagliptin 5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0410 |