Quick answers
- What is Dapagliflozin used for?
- The FDA-approved label (Farxiga, A-S Medication Solutions, July 10, 2026) says: “FARXIGA (dapagliflozin) is indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dapagliflozin have a boxed warning?
- No. None of the 23 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dapagliflozin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Dapagliflozin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Dapagliflozin?
- 24 companies list prescription products of Dapagliflozin in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Sandoz Inc.
What Dapagliflozin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FARXIGA (dapagliflozin) is indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of CV death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. …
— FDA label: Farxiga, A-S Medication Solutions, effective July 10, 2026. Read the full label on DailyMed →
The FDA has 23 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 23 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 50 in the FDA NDC Directory |
| Brand names | Farxiga |
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 10 mg tablet | Generic | $0.1845 per tablet |
| dapagliflozin 10 mg tablet, film coated | Generic | $0.1845 per tablet |
| dapagliflozin 5 mg tablet | Generic | $0.1631 per tablet |
| dapagliflozin 5 mg tablet, film coated | Generic | $0.1631 per tablet |
| dapagliflozin propanediol 10 mg tablet, film coated | Generic | $0.1845 per tablet |
| dapagliflozin propanediol 10 mg tablet, film coated | Brand: Farxiga | $12.08 per tablet |
| dapagliflozin propanediol 5 mg tablet, film coated | Generic | $0.1631 per tablet |
| dapagliflozin propanediol 5 mg tablet, film coated | Brand: Farxiga | $12.07 per tablet |
NADAC list of November 4, 2026; these prices took effect between October 21, 2026 and October 28, 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 Solutions6 products
- Bryant Ranch Prepack2 products
- Sandoz Inc2 products
- Aurobindo Pharma Limited2 products
- Florida Pharmaceutical Products, LLC2 products
- Novadoz Pharmaceuticals LLC2 products
- Zydus Pharmaceuticals USA Inc.2 products
- ANI Pharmaceuticals, Inc.2 products
- Alembic Pharmaceuticals Limited2 products
- AvKARE2 products
- Micro Labs Limited2 products
- Apotex Corp.2 products
- Alembic Pharmaceuticals Inc.2 products
- Ascend Laboratories, LLC2 products
- Zydus Lifesciences Limited2 products
- Lupin Pharmaceuticals, Inc.2 products
- Macleods Pharmaceuticals Limited2 products
- Ajanta Pharma USA Inc.2 products
- Teva Pharmaceuticals, Inc.2 products
- AstraZeneca Pharmaceuticals LP2 products
- Prasco Laboratories2 products
- Cipla USA Inc.2 products
- Redpharm Drug1 product
- Remedyrepack Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA202293 FARXIGA | Astrazeneca Ab | January 8, 2014 | 23, latest June 3, 2026 2026: Labeling · 2024: Efficacy · 2023: Labeling |
Generic approvals (14)
- ANDA211156Inventia · April 6, 2026
- ANDA211312Sandoz · April 6, 2026
- ANDA211467Micro Labs · April 6, 2026
- ANDA211468Aurobindo Pharma · April 6, 2026
- ANDA211478Msn · April 6, 2026
- ANDA211482Ajanta Pharma Ltd · April 6, 2026
- ANDA211506Macleods Pharms · April 6, 2026
- ANDA211523Aizant · April 6, 2026
- ANDA211531Lupin · April 6, 2026
- ANDA211535Cipla · April 6, 2026
- ANDA211541Teva Pharms USA · April 6, 2026
- ANDA211545Alkem Labs Ltd · April 6, 2026
- ANDA211560Alembic · April 6, 2026
- ANDA211582Zydus Pharms · April 6, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1486977, 1486981, 1488569, 1488574 |
|---|---|
| SPL set ID of the quoted label | 01f90c94-71cb-4a1f-81ff-8004b850529b |
| FDA labels (SPL) | 23 |
| FDA applications | NDA202293, 14 ANDA |
| Active ingredients (FDA) | DAPAGLIFLOZIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Farxiga, A-S Medication Solutions, effective July 10, 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 →