Prescription drug · ANDA
Spironolactone NDC 60687-476
Spironolactone 50 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-476-01 | 60687047601 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-476-01) / 1 TABLET in 1 BLISTER PACK (60687-476-11)Marketed from Jun 6, 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)
- Spironolactone
- Generic name (nonproprietary)
- spironolactone
- Active ingredients
- Spironolactone — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205936
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 60687-476_24ae6e13-ec56-15c1-e063-6394a90a8845SPL ID 24ae6e13-ec56-15c1-e063-6394a90a8845SPL set ID bd5ec154-b092-4c4d-8e72-ca2a2ef71a6dRxCUI 198222, 198223, 313096UNII 27O7W4T232
- Pharmacologic class
- Aldosterone Antagonist
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
N460687047601followed by a unit qualifier and the quantityPackage 60687-0476-01. 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)
Spironolactone is an aldosterone antagonist indicated for: The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure (1.1) . Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (1.2) . The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sod…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205936
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 |
|---|---|---|---|---|
| spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-861 |
| spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1029 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1027 |
| spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1028 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | American Health Packaging | 60687-487 |
| spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4468 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3556 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4470 |
| spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4512 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 68382-660 |
| spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 68382-661 |
| spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 68382-662 |
| spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-153 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-636 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6927 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | American Health Packaging | 60687-465 |