Quick answers
- What is Edetate calcium disodium used for?
- The FDA-approved label (Edetate Calcium Disodium, Rising Pharma Holdings, Inc., February 13, 2025) says: “Edetate calcium disodium is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Edetate calcium disodium have a boxed warning?
- Yes. The FDA label for Edetate Calcium Disodium has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Edetate calcium disodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Edetate calcium disodium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Edetate calcium disodium?
- 1 company lists prescription products of Edetate calcium disodium in the FDA NDC Directory, including Rising Pharma Holdings, Inc..
What Edetate calcium disodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Edetate calcium disodium is indicated for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy, in both pediatric populations and adults. Chelation therapy should not replace effective measures to eliminate or reduce further exposure to lead.
— FDA label: Edetate Calcium Disodium, Rising Pharma Holdings, Inc., effective February 13, 2025. 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.
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. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intramuscular · Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
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.
- Rising Pharma Holdings, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA216435Casper Pharma LLC · May 3, 2023
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) | 847703 |
|---|---|
| SPL set ID of the quoted label | 710a2c8c-3620-4f6f-b8fc-fb19ab9e9f22 |
| FDA labels (SPL) | 1 |
| FDA applications | 1 ANDA |
| Active ingredients (FDA) | EDETATE CALCIUM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Edetate Calcium Disodium, Rising Pharma Holdings, Inc., effective February 13, 2025; 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 →