Quick answers
- What is Calcium acetate used for?
- The FDA-approved label (Calcium Acetate, American Health Packaging, September 4, 2026) says: “Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Calcium acetate have a boxed warning?
- No. None of the 21 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Calcium acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Calcium acetate been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 15, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Calcium acetate?
- 19 companies list prescription products of Calcium acetate in the FDA NDC Directory, including Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Chartwell RX, LLC and American Health Packaging.
What Calcium acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.
— FDA label: Calcium Acetate, American Health Packaging, effective September 4, 2026. Read the full label on DailyMed →
The FDA has 21 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.
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 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 22 in the FDA NDC Directory |
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 |
|---|---|---|
| calcium acetate 667 mg capsule | Generic | $0.1757 per capsule |
| calcium acetate 667 mg tablet | Generic | $0.3885 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.
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- Chartwell RX, LLC2 products
- American Health Packaging2 products
- Major Pharmaceuticals1 product
- Rising Pharma Holdings, Inc.1 product
- Amneal Pharmaceuticals of New York LLC1 product
- Cipla USA Inc.1 product
- Proficient Rx LP1 product
- Westminster Pharmaceuticals, LLC1 product
- Nivagen Pharmaceuticals, Inc.1 product
- Exelan Pharmaceuticals Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Remedyrepack Inc.1 product
- AvKARE1 product
- Square Pharmaceuticals Limited1 product
- AvPAK1 product
- Cardinal Health 107, LLC1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- NCS HealthCare of KY, LLC dba Vangard Labs1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (10)
- ANDA077728Hikma · February 26, 2008
- ANDA091312Chartwell Rx · June 1, 2012
- ANDA202420Chartwell Molecular · February 5, 2013
- ANDA203135Invagen Pharms · February 7, 2013
- ANDA201658Amneal Pharms · October 6, 2014
- ANDA202885Heritage Pharms Inc · January 22, 2015
- ANDA202315Heritage Pharms Inc · June 29, 2015
- ANDA203179Mpp Pharma · October 26, 2015
- ANDA211038Cohance Lifesciences · February 21, 2020
- ANDA217205Adaptis · March 13, 2023
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-0491-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 — 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) | 197433, 359296 |
|---|---|
| SPL set ID of the quoted label | 2072d9f4-abb1-4699-bde5-6041dd79cad5 |
| FDA labels (SPL) | 21 |
| FDA applications | 10 ANDA |
| Active ingredients (FDA) | CALCIUM ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Calcium Acetate, American Health Packaging, effective September 4, 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 →