Prescription drug · NDA
Tradjenta (Linagliptin) NDC 55154-0410
Linagliptin 5 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-0410-8 | 55154041008 | 2640 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0410-8)Marketed from May 9, 2011 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Cardinal Health 107, LLCNDC labeler code 55154
- 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 55154-0410_195b6992-7ffb-4fb1-a959-74345e5060f4SPL ID 195b6992-7ffb-4fb1-a959-74345e5060f4SPL set ID dfe327e8-f6ab-41e5-bdef-d520118cd83aRxCUI 1100702, 1100706UNII 3X29ZEJ4R2UPC 0355154041080
- 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
N455154041008followed by a unit qualifier and the quantityPackage 55154-0410-08. 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 wh…
Excerpt only. Read the full label for complete information.
About NDC 55154-0410
- What is NDC 55154-0410?
- 55154-0410 is the product NDC for Tradjenta (linagliptin), Linagliptin 5 mg/1 tablet, film coated, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, 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?
- Cardinal Health 107, LLC, NDC labeler code 55154. 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 | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0140 | 00597-0140-3000597-0140-6100597-0140-90 |
| Tradjentalinagliptin | Linagliptin 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4383 | 50090-4383-00 |
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 | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0140 |
| Tradjentalinagliptin | Linagliptin 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4383 |