Quick answers
- What is Edarbi?
- Edarbi is a brand name of Azilsartan kamedoxomil, a prescription medicine. The FDA NDC Directory lists 2 Edarbi products in 2 strengths and forms.
- Who makes Edarbi?
- Azurity holds the FDA application for Edarbi (NDA200796, approved February 25, 2011).
- Is there a generic or store brand of Edarbi?
- Yes. The FDA NDC Directory lists 4 other products with the same active ingredients, strength and form as a Edarbi product, 2 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Edarbi?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Edarbi 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 Edarbi been recalled?
- FDA enforcement reports list 1 recall of Edarbi products; the newest started March 15, 2021. A recall usually concerns specific lots, not every product.
What Edarbi is
Each Edarbi 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.
Azilsartan kamedoxomil · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| azilsartan kamedoxomil 40 mg tablet (oral) | Edarbi | 2 products, 2 companies | DailyMed |
| azilsartan kamedoxomil 80 mg tablet (oral) | Edarbi | 2 products, 2 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Azilsartan kamedoxomil →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA200796 | Azurity | February 25, 2011 | 2 |
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 |
|---|---|---|
| azilsartan kamedoxomil 40 mg tablet | Brand: Edarbi | $8.28 per tablet Generic of the same strength and form: $5.51 per tablet |
| azilsartan kamedoxomil 80 mg tablet | Brand: Edarbi | $9.01 per tablet Generic of the same strength and form: $5.72 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 Edarbi
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Edarbi products.
- Azurity Pharmaceuticals, Inc.2 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-0429-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328 — 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.