Prescription drug · ANDA
Spironolactone NDC 72189-497
Spironolactone 25 mg/1 · Tablet, Coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-497-30 | 72189049730 | 30 TABLET, COATED in 1 BOTTLE (72189-497-30)Marketed from Jul 6, 2023 | |
| 72189-497-90 | 72189049790 | 90 TABLET, COATED in 1 BOTTLE (72189-497-90)Marketed from Jul 6, 2023 |
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 — 25 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040750
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 72189-497_4c4b0c1a-d843-08bc-e063-6394a90ad546SPL ID 4c4b0c1a-d843-08bc-e063-6394a90ad546SPL set ID ffd2f3f5-c7c8-0028-e053-6394a90aaf17RxCUI 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
N472189049730followed by a unit qualifier and the quantityPackage 72189-0497-30. 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)
1.1 Heart Failure Spironolactone is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. Spironolactone is usually administered in conjunction with other heart failure therapies. 1.2 Hypertension Spironolactone is indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive dr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040750
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 | Tablet, CoatedOral | Proficient Rx LP | 82804-977 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 82804-975 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 82804-976 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-6369 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, CoatedOral | Asclemed USA, Inc. | 76420-927 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Asclemed USA, Inc. | 76420-925 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | Asclemed USA, Inc. | 76420-926 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, CoatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-292 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-290 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-291 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-8545 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-6458 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Oxford Pharmaceuticals, LLC | 69584-852 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-0613 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | Oxford Pharmaceuticals, LLC | 69584-853 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, CoatedOral | Oxford Pharmaceuticals, LLC | 69584-854 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, CoatedOral | Direct_Rx | 72189-495 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 82804-205 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | Direct_Rx | 72189-496 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-0744 |
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