Active ingredient
Linagliptin
3 finished FDA listings contain Linagliptin as their only active ingredient; 14 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- LINAGLIPTIN
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 5 mg/1
- Brand names in FDA listings
- Tradjenta
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1100699
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 201280 | BOEHRINGER INGELHEIM | 2011-05-02 | 3 |
Official labeling on DailyMed
- TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 12 · 2025-09-08
- TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] · version 32 · 2025-03-27
- TRADJENTA (LINAGLIPTIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 8 · 2024-01-23
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.