Prescription drug · NDA
Edecrin (Ethacrynic acid) NDC 25010-215
Ethacrynic acid 25 mg/1 · Tablet · Oral · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25010-215-15 | 2501002151525010021515 | 100 TABLET in 1 BOTTLE (25010-215-15)Marketed from Jan 10, 1967 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Edecrin
- Generic name (nonproprietary)
- ethacrynic acid
- Active ingredients
- Ethacrynic acid — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bausch Health US, LLCNDC labeler code 25010
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016092
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 25010-215_4c442b87-1bbd-40e6-8c40-004f5f46e996SPL ID 4c442b87-1bbd-40e6-8c40-004f5f46e996SPL set ID 1efe378e-fee1-4ae9-8ea5-0fe2265fe2d8RxCUI 211509, 617325, 1251903, 1251905UNII M5DP350VZVUPC 0325010215153
- Pharmacologic class
- Loop Diuretic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N425010021515followed by a unit qualifier and the quantityPackage 25010-0215-15. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE EDECRIN 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. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4. Intravenous SODIUM EDECRIN is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral …
Excerpt only. Read the full label for complete information.
About NDC 25010-215
- What is NDC 25010-215?
- 25010-215 is the product NDC for Edecrin (ethacrynic acid), Ethacrynic acid 25 mg/1 tablet, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Edecrin (Ethacrynic acid).
- What is the active ingredient?
- Ethacrynic acid.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 25010. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Edecrin?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 016092
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| ethacrynic acid | Ethacrynic acid 25 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-011 |