Quick answers
- What is Azilsartan kamedoxomil and chlorthalidone used for?
- The FDA-approved label (Edarbyclor, Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals), July 1, 2022) says: “Edarbyclor is indicated for the treatment of hypertension, to lower blood pressure. Edarbyclor may be used in patients whose blood pressure is not adequately controlled on monotherapy. Edarbyclor may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Azilsartan kamedoxomil and chlorthalidone have a boxed warning?
- Yes. The FDA label for Edarbyclor has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Azilsartan kamedoxomil and chlorthalidone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Azilsartan kamedoxomil and chlorthalidone been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Azilsartan kamedoxomil and chlorthalidone?
- 1 company lists prescription products of Azilsartan kamedoxomil and chlorthalidone in the FDA NDC Directory, including Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals).
What Azilsartan kamedoxomil and chlorthalidone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Edarbyclor is indicated for the treatment of hypertension, to lower blood pressure. Edarbyclor may be used in patients whose blood pressure is not adequately controlled on monotherapy. Edarbyclor may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. …
— FDA label: Edarbyclor, Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals), effective July 1, 2022. Read the full label on DailyMed →
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.
This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Edarbyclor |
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 · chlorthalidone 12.5 mg tablet | Brand: Edarbyclor | $8.50 per tablet |
| azilsartan kamedoxomil 40 mg · chlorthalidone 25 mg tablet | Brand: Edarbyclor | $8.49 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.
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA202331 EDARBYCLOR | Azurity | December 20, 2011 | 8, latest March 9, 2020 2020: Labeling · 2016: Labeling · 2015: Manufacturing (CMC) |
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 15, 2021 · Class II · Terminated · D-0431-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 6 — Cardinal Health Inc.
-
March 15, 2021 · Class II · Terminated · D-0430-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328 — Cardinal Health Inc.
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) | 1235144, 1235150, 1235151, 1235157 |
|---|---|
| SPL set ID of the quoted label | e60f795b-fce3-4361-aa03-f143451689d1 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA202331 |
| Active ingredients (FDA) | AZILSARTAN KAMEDOXOMIL / CHLORTHALIDONE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Edarbyclor, Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals), effective July 1, 2022; 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 →