Active ingredient
Empagliflozin
11 finished FDA listings contain Empagliflozin as their only active ingredient; 14 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- EMPAGLIFLOZIN
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 5
- Strengths listed
- 10 mg/1 · 25 mg/1
- Brand names in FDA listings
- Jardiance
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1545653
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 204629 | BOEHRINGER INGELHEIM | 2014-08-01 | 11 |
Official labeling on DailyMed
- JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [REDPHARM DRUG] · version 1 · 2026-08-27
- JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] · version 2 · 2026-06-22
- JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] · version 13 · 2026-02-23
- JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] · version 31 · 2026-02-02
- JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] · version 4 · 2025-11-17
- JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 11 · 2023-08-10
- JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 9 · 2023-07-25
- JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 1 · 2023-05-04
- JARDIANCE (EMPAGLIFLOZIN) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] · version 1 · 2023-05-04
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.