Quick answers
- What is Synjardy XR?
- Synjardy XR is a brand name of Empagliflozin, metformin hydrochloride, a prescription medicine. The FDA NDC Directory lists 4 Synjardy XR products in 4 strengths and forms.
- Who makes Synjardy XR?
- Boehringer Ingelheim holds the FDA application for Synjardy XR (NDA208658, approved December 9, 2016).
- Is there a generic or store brand of Synjardy XR?
- Other products of Empagliflozin, metformin hydrochloride are listed with the FDA, but none in exactly the same strength and form as a Synjardy XR product.
- What do pharmacies pay for Synjardy XR?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 4 Synjardy XR strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Synjardy XR been recalled?
- FDA enforcement reports list 2 recalls of Synjardy XR products; the newest started March 15, 2021. A recall usually concerns specific lots, not every product.
What Synjardy XR is
Each Synjardy XR product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Empagliflozin, metformin hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| empagliflozin 10 mg · metformin hydrochloride 1000 mg tablet, extended release (oral) | Synjardy XR | None listed | DailyMed |
| empagliflozin 12.5 mg · metformin hydrochloride 1000 mg tablet, extended release (oral) | Synjardy XR | None listed | DailyMed |
| empagliflozin 25 mg · metformin hydrochloride 1000 mg tablet, extended release (oral) | Synjardy XR | None listed | DailyMed |
| empagliflozin 5 mg · metformin hydrochloride 1000 mg tablet, extended release (oral) | Synjardy XR | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Empagliflozin, metformin hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA208658 | Boehringer Ingelheim | December 9, 2016 | 4 |
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 · metformin hydrochloride 1000 mg tablet, extended release | Brand: Synjardy XR | $11.21 per tablet |
| empagliflozin 12.5 mg · metformin hydrochloride 1000 mg tablet, extended release | Brand: Synjardy XR | $5.60 per tablet |
| empagliflozin 25 mg · metformin hydrochloride 1000 mg tablet, extended release | Brand: Synjardy XR | $11.19 per tablet |
| empagliflozin 5 mg · metformin hydrochloride 1000 mg tablet, extended release | Brand: Synjardy XR | $5.61 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 Synjardy XR
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Synjardy XR products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 15, 2021 · Class II · Terminated · D-0458-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA — Cardinal Health Inc.
-
March 15, 2021 · Class II · Terminated · D-0459-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA — Cardinal Health Inc.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.