Prescription drug · ANDA
Ethacrynate Sodium NDC 69315-701
Ethacrynate sodium 50 mg/50mL · Injection, Powder, Lyophilized, For solution · Intravenous · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-701-50 | 69315070150 | 1 VIAL, SINGLE-DOSE in 1 CARTON (69315-701-50) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 9, 2026 |
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)
- Ethacrynate Sodium
- Generic name (nonproprietary)
- ethacrynate sodium
- Active ingredients
- Ethacrynate sodium — 50 mg/50mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Leading Pharma, LLCNDC labeler code 69315
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208663
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 69315-701_f2c45a04-b3df-48cd-93e2-edb917a029cfSPL ID f2c45a04-b3df-48cd-93e2-edb917a029cfSPL set ID e24e7440-a958-6fd0-6bfe-1bd29e638657RxCUI 617325UNII K41MYV7MPMUPC 0369315701508
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N469315070150followed by a unit qualifier and the quantityPackage 69315-0701-50. 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 Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or ora…
Excerpt only. Read the full label for complete information.
About NDC 69315-701
- What is NDC 69315-701?
- 69315-701 is the product NDC for Ethacrynate Sodium, Ethacrynate sodium 50 mg/50mL injection, powder, lyophilized, for solution, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ethacrynate Sodium.
- What is the active ingredient?
- Ethacrynate sodium.
- Who is the labeler?
- Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ethacrynate Sodium?
- 1 other product NDC are listed under this name. See all Ethacrynate Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ethacrynate Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ethacrynate Sodium | Ethacrynate sodium 50 mg/50mL | Injection, Powder, For solutionIntravenous | Par Health USA, LLC | 42023-157 | 42023-0157-01 |