Quick answers
- What is Ethacrynate sodium used for?
- The FDA-approved label (Ethacrynate Sodium, Par Health USA, LLC, August 21, 2026) says: “Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ethacrynate sodium have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ethacrynate sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ethacrynate sodium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ethacrynate sodium?
- 2 companies list prescription products of Ethacrynate sodium in the FDA NDC Directory, including Par Health USA, LLC and Leading Pharma, LLC.
What Ethacrynate sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. …
— FDA label: Ethacrynate Sodium, Par Health USA, LLC, effective August 21, 2026. Read the full label on DailyMed →
The FDA has 2 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 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 2 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.
- Par Health USA, LLC1 product
- Leading Pharma, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA205473Ph Health · July 29, 2015
- ANDA208663Sterimax · June 9, 2020
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) | 617325 |
|---|---|
| SPL set ID of the quoted label | 3313ed5d-7991-408f-872b-d5a701aa6d83 |
| FDA labels (SPL) | 2 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | ETHACRYNATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ethacrynate Sodium, Par Health USA, LLC, effective August 21, 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 →