Prescription drug · ANDA
Spironolactone NDC 53746-515
Spironolactone 100 mg/1 · Tablet · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53746-515-01 | 53746051501 | 100 TABLET in 1 BOTTLE (53746-515-01)Marketed from Aug 2, 2010 | |
| 53746-515-05 | 53746051505 | 500 TABLET in 1 BOTTLE (53746-515-05)Marketed from Aug 2, 2010 | |
| 53746-515-10 | 53746051510 | 1000 TABLET in 1 BOTTLE (53746-515-10)Marketed from Aug 2, 2010 | |
| 53746-515-30 | 53746051530 | 30 TABLET in 1 BOTTLE (53746-515-30)Marketed from Aug 2, 2010 | |
| 53746-515-60 | 53746051560 | 60 TABLET in 1 BOTTLE (53746-515-60)Marketed from Aug 2, 2010 | |
| 53746-515-90 | 53746051590 | 90 TABLET in 1 BOTTLE (53746-515-90)Marketed from Aug 2, 2010 |
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 — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091426
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 53746-515_0b757d66-e1f0-4d56-bbe0-2f0941f0a35eSPL ID 0b757d66-e1f0-4d56-bbe0-2f0941f0a35eSPL set ID 951b8948-dc0f-4aef-9910-82c252de936dRxCUI 198222, 198223, 313096UNII 27O7W4T232UPC 0353746514301, 0353746511300, 0353746515308
- 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
N453746051501followed by a unit qualifier and the quantityPackage 53746-0515-01. 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 tablets are 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 fl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091426
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 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0966 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-102 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | PharmPak, Inc. | 54348-340 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-514 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-511 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | QPharma, Inc | 42708-126 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-511 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-514 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-515 |