Prescription drug · NDA
Aldactone (spironolactone) NDC 0025-1041
Spironolactone 50 mg/1 · Tablet, Film coated · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0025-1041-31 | 00025104131 | 100 TABLET, FILM COATED in 1 BOTTLE (0025-1041-31)Marketed from Jan 21, 1960 |
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)
- Aldactone
- Generic name (nonproprietary)
- spironolactone
- Active ingredients
- Spironolactone — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 012151
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 0025-1041_22946678-dcad-4518-9bc6-cbdf51a38c16SPL ID 22946678-dcad-4518-9bc6-cbdf51a38c16SPL set ID 0fed2822-3a03-4b64-9857-c682fcd462bcRxCUI 198222, 198223, 200817, 200820, 200825, 313096UNII 27O7W4T232UPC 0300251001314, 0300251031311, 0300251041310
- 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
N400025104131followed by a unit qualifier and the quantityPackage 00025-1041-31. 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)
ALDACTONE 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 012151
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 |
|---|---|---|---|---|
| Aldactonespironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0025-1031 |
| Aldactonespironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0025-1001 |