Active ingredient
Saxagliptin
6 finished FDA listings contain Saxagliptin as their only active ingredient; 7 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- SAXAGLIPTIN, SAXAGLIPTIN HYDROCHLORIDE, SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 2.5 mg/1 · 5 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 857974
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 |
|---|---|---|---|
| ANDA 205972 | AUROBINDO PHARMA | 2023-07-31 | 2 |
| ANDA 205980 | MYLAN | 2023-07-31 | 2 |
| ANDA 205994 | GLENMARK PHARMS LTD | 2023-07-31 | 2 |
Official labeling on DailyMed
- SAXAGLIPTIN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] · version 2 · 2026-01-28
- SAXAGLIPTIN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] · version 4 · 2025-03-24
- SAXAGLIPTIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 3 · 2024-12-12
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.