Prescription drug · ANDA
Ethacrynic Acid NDC 0832-1690
Ethacrynic acid 25 mg/1 · Tablet · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-1690-11 | 0083216901100832169011 | 100 TABLET in 1 BOTTLE (0832-1690-11)Marketed from Feb 19, 2020 | |
| 0832-1690-30 | 0083216903000832169030 | 30 TABLET in 1 BOTTLE (0832-1690-30)Marketed from Feb 19, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Upsher-Smith Laboratories, LLCNDC labeler code 0832
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212417
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 0832-1690_55f58d26-93c1-ab8a-e063-6394a90a73c1SPL ID 55f58d26-93c1-ab8a-e063-6394a90a73c1SPL set ID c0b17629-7e4a-4c9c-9577-4f7904564628RxCUI 1251903UNII M5DP350VZVUPC 0308321690307
- 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
N400832169011followed by a unit qualifier and the quantityPackage 00832-1690-11. 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 Ethacrynic acid tablets 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 impaired…
Excerpt only. Read the full label for complete information.
About NDC 0832-1690
- What is NDC 0832-1690?
- 0832-1690 is the product NDC for Ethacrynic Acid, Ethacrynic acid 25 mg/1 tablet, listed with the FDA by Upsher-Smith Laboratories, 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?
- Upsher-Smith Laboratories, LLC, NDC labeler code 0832. 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 | TRUPHARMA LLC | 52817-367 | 52817-0367-1052817-0367-90 |
| 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 |