NDC 0597-0140
Tradjenta
Linagliptin
Tradjenta is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Linagliptin.
| Product ID | 0597-0140_1135e6c8-c2ae-d958-20ba-6c1eda889aa2 |
| NDC | 0597-0140 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Tradjenta |
| Generic Name | Linagliptin |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2011-05-09 |
| Marketing Category | NDA / NDA |
| Application Number | NDA201280 |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Substance Name | LINAGLIPTIN |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | Dipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 0597-0140-30
30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30)
| Marketing Start Date | 2011-05-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0597-0140-90 [00597014090]
Tradjenta TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA201280 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-05-09 |
NDC 0597-0140-70 [00597014070]
Tradjenta TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA201280 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-05-09 |
NDC 0597-0140-61 [00597014061]
Tradjenta TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA201280 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-05-09 |
NDC 0597-0140-30 [00597014030]
Tradjenta TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA201280 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2011-05-09 |
NDC 0597-0140-10 [00597014010]
Tradjenta TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA201280 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2011-05-09 |
| Marketing End Date | 2012-10-11 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| LINAGLIPTIN | 5 mg/1 |
OpenFDA Data
| SPL SET ID: | c797ea5c-cab7-494b-9044-27eba0cfe40f |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Dipeptidyl Peptidase 4 Inhibitors [MoA]
- Dipeptidyl Peptidase 4 Inhibitor [EPC]
NDC Crossover Matching brand name "Tradjenta" or generic name "Linagliptin"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0597-0140 | Tradjenta | linagliptin |
| 50090-4383 | Tradjenta | linagliptin |
| 55154-0410 | Tradjenta | linagliptin |
Trademark Results [Tradjenta]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRADJENTA 85223216 4103139 Live/Registered |
Boehringer Ingelheim International GmbH 2011-01-21 |
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