Quick answers
- What is Xigduo XR?
- Xigduo XR is a brand name of Dapagliflozin and metformin hydrochloride, a prescription medicine. The FDA NDC Directory lists 5 Xigduo XR products in 5 strengths and forms.
- Who makes Xigduo XR?
- Astrazeneca Ab holds the FDA application for Xigduo XR (NDA205649, approved October 29, 2014).
- Is there a generic or store brand of Xigduo XR?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Xigduo XR product, 2 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Xigduo XR?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 5 Xigduo 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 Xigduo XR been recalled?
- FDA enforcement reports list 2 recalls of Xigduo XR products; the newest started March 15, 2021. A recall usually concerns specific lots, not every product.
What Xigduo XR is
Each Xigduo 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.
Dapagliflozin and metformin hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dapagliflozin propanediol 10 mg · metformin hydrochloride 1000 mg tablet, film coated, extended release (oral) | Xigduo XR | 1 product, 1 company | DailyMed |
| dapagliflozin propanediol 10 mg · metformin hydrochloride 500 mg tablet, film coated, extended release (oral) | Xigduo XR | None listed | DailyMed |
| dapagliflozin propanediol 2.5 mg · metformin hydrochloride 1000 mg tablet, film coated, extended release (oral) | Xigduo XR | None listed | DailyMed |
| dapagliflozin propanediol 5 mg · metformin hydrochloride 1000 mg tablet, film coated, extended release (oral) | Xigduo XR | 1 product, 1 company | DailyMed |
| dapagliflozin propanediol 5 mg · metformin hydrochloride 500 mg tablet, film coated, extended release (oral) | Xigduo XR | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Dapagliflozin and metformin hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA205649 | Astrazeneca Ab | October 29, 2014 | 5 |
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 |
|---|---|---|
| dapagliflozin propanediol 10 mg · metformin hydrochloride 1000 mg tablet, film coated, extended release | Brand: Xigduo XR | $19.20 per tablet Generic of the same strength and form: $0.8146 per tablet |
| dapagliflozin propanediol 10 mg · metformin hydrochloride 500 mg tablet, film coated, extended release | Brand: Xigduo XR | $19.23 per tablet |
| dapagliflozin propanediol 2.5 mg · metformin hydrochloride 1000 mg tablet, film coated, extended release | Brand: Xigduo XR | $9.61 per tablet |
| dapagliflozin propanediol 5 mg · metformin hydrochloride 1000 mg tablet, film coated, extended release | Brand: Xigduo XR | $9.59 per tablet Generic of the same strength and form: $0.4871 per tablet |
| dapagliflozin propanediol 5 mg · metformin hydrochloride 500 mg tablet, film coated, extended release | Brand: Xigduo XR | $19.18 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 Xigduo XR
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Xigduo XR products.
- AstraZeneca Pharmaceuticals LP5 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-0436-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 — Cardinal Health Inc.
-
March 15, 2021 · Class II · Terminated · D-0435-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squib — 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.