Prescription drug · ANDA
Spironolactone NDC 50090-6539
Spironolactone 100 mg/1 · Tablet, Coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6539-0 | 50090653900 | 90 TABLET, COATED in 1 BOTTLE (50090-6539-0)Marketed from Jun 29, 2023 | |
| 50090-6539-1 | 50090653901 | 30 TABLET, COATED in 1 BOTTLE (50090-6539-1)Marketed from Jun 29, 2023 |
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)
- Spironolactone
- Generic name (nonproprietary)
- spironolactone
- Active ingredients
- Spironolactone — 100 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- 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 50090-6539_76b5d6ad-0b7b-4781-b990-5ba036cf5a67SPL ID 76b5d6ad-0b7b-4781-b990-5ba036cf5a67SPL set ID 08738ad4-1607-4d55-af71-6790477353bdRxCUI 198222UNII 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
N450090653900followed by a unit qualifier and the quantityPackage 50090-6539-00. 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 s…
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 25 mg/1 | Tablet, CoatedOral | Direct_Rx | 72189-497 |
| 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 |
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