Prescription drug · NDA
Furosemide NDC 63561-0166
Furosemide 80 mg/1 · Tablet · Oral · Granulation Technology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63561-0166-1 | 63561016601 | 100 TABLET in 1 BOTTLE (63561-0166-1)Marketed from Jan 15, 2026 | |
| 63561-0166-5 | 63561016605 | 500 TABLET in 1 BOTTLE (63561-0166-5)Marketed from Dec 18, 2025 | |
| 63561-0166-9 | 63561016609 | 90 TABLET in 1 BOTTLE (63561-0166-9)Marketed from Dec 18, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Furosemide
- Generic name (nonproprietary)
- furosemide
- Active ingredients
- Furosemide — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Granulation Technology, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018569
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis at Loop of Henle (Physiologic effect)
- Identifiers
- Product ID 63561-0166_54741cba-d4ee-617e-e063-6294a90ad1ebSPL ID 54741cba-d4ee-617e-e063-6294a90ad1ebSPL set ID 462e8917-cbe0-f4f9-e063-6394a90ab4ffRxCUI 197732, 310429, 313988UNII 7LXU5N7ZO5UPC 0363561016614, 0363561016522, 0363561016515, 0363561016690, 0363561016591, 0363561016492, 0363561016423, 0363561016652
- 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
N463561016601followed by a unit qualifier and the quantityPackage 63561-0166-01. 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 Edema Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Hypertension Oral Furosemide may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with Furosemide alone.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 018569
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 |
|---|---|---|---|---|
| Furosemide | Furosemide 20 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-832 |
| Furosemide | Furosemide 40 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-833 |
| Furosemide | Furosemide 80 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-834 |
| Furosemide | Furosemide 40 mg/1 | TabletOral | Granulation Technology, Inc. | 63561-0165 |
| Furosemide | Furosemide 20 mg/1 | TabletOral | Granulation Technology, Inc. | 63561-0164 |