Prescription drug · ANDA
Ethacrynic acid NDC 52817-367
Ethacrynic acid 25 mg/1 · Tablet · Oral · TRUPHARMA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-367-10 | 5281703671052817036710 | 100 TABLET in 1 BOTTLE (52817-367-10)Marketed from Sep 12, 2019 | |
| 52817-367-90 | 5281703679052817036790 | 90 TABLET in 1 BOTTLE (52817-367-90)Marketed from Sep 12, 2019 |
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)
- Ethacrynic acid
- Generic name (nonproprietary)
- ethacrynic acid
- Active ingredients
- Ethacrynic acid — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TRUPHARMA LLCNDC labeler code 52817
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211809
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 52817-367_fb026274-f2ff-4316-adcf-2590aabf5a76SPL ID fb026274-f2ff-4316-adcf-2590aabf5a76SPL set ID 3b2b6ee1-1859-4b02-9ef2-5bbe6427f61aRxCUI 1251903UNII M5DP350VZVUPC 0352817367907, 0352817367105
- 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
N452817036710followed by a unit qualifier and the quantityPackage 52817-0367-10. 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 & USAGE Ethacrynic Acid Tablets USP, are 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 impai…
Excerpt only. Read the full label for complete information.
About NDC 52817-367
- What is NDC 52817-367?
- 52817-367 is the product NDC for Ethacrynic acid, Ethacrynic acid 25 mg/1 tablet, listed with the FDA by TRUPHARMA LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ethacrynic acid.
- What is the active ingredient?
- Ethacrynic acid.
- Who is the labeler?
- TRUPHARMA LLC, NDC labeler code 52817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ethacrynic acid?
- 8 other product NDCs are listed under this name. See all Ethacrynic acid NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ethacrynic acid products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ethacrynic Acid | Ethacrynic acid 25 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-773 | 60760-0773-3060760-0773-60 |
| Ethacrynic Acid | Ethacrynic acid 25 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-159 | 68180-0159-01 |
| Ethacrynic Acid | Ethacrynic acid 25 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 0832-1690 | 00832-1690-1100832-1690-30 |
| Ethacrynic Acid | Ethacrynic acid 25 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-334 | 50228-0334-0150228-0334-1050228-0334-30 |
| Ethacrynic Acid | Ethacrynic acid 25 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2257 | 72162-2257-01 |
| Ethacrynic Acid | Ethacrynic acid 25 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1126 | 69238-1126-01 |
| Ethacrynic Acid | Ethacrynic acid 25 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-405 | 42799-0405-01 |
| ethacrynic acid | Ethacrynic acid 25 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-011 | 68682-0011-10 |