Quick answers
- What is Empagliflozin used for?
- The FDA-approved label (Jardiance, Redpharm Drug, August 26, 2026) says: “JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Empagliflozin have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Empagliflozin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Empagliflozin been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 9, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Empagliflozin?
- 5 companies list prescription products of Empagliflozin in the FDA NDC Directory, including A-S Medication Solutions, Aphena Pharma Solutions - Tennessee, LLC and Cardinal Health 107, LLC.
What Empagliflozin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
JARDIANCE is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression. …
— FDA label: Jardiance, Redpharm Drug, effective August 26, 2026. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 11 in the FDA NDC Directory |
| Brand names | Jardiance |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| empagliflozin 10 mg tablet, film coated | Brand: Jardiance | $11.19 per tablet |
| empagliflozin 25 mg tablet, film coated | Brand: Jardiance | $11.19 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions4 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- Cardinal Health 107, LLC2 products
- Boehringer Ingelheim Pharmaceuticals, Inc.2 products
- Redpharm Drug1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204629 JARDIANCE | Boehringer Ingelheim | August 1, 2014 | 25, latest October 24, 2025 2025: Labeling · 2023: Efficacy · 2023: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 9, 2023 · Class II · Terminated · D-0468-2023
Labeling: Label Mix-up
JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA an — Boehringer Ingelheim Pharmaceuticals, Inc.
-
January 26, 2022 · Class II · Terminated · D-0185-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37 — CARDINAL HEALTHCARE
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1545658, 1545664, 1545666, 1545668 |
|---|---|
| SPL set ID of the quoted label | 59ed43d9-b4e0-72a2-e063-6394a90a327d |
| FDA labels (SPL) | 9 |
| FDA applications | NDA204629 |
| Active ingredients (FDA) | EMPAGLIFLOZIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Jardiance, Redpharm Drug, effective August 26, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →