Prescription drug · ANDA
Spironolactone NDC 51655-344
Spironolactone 100 mg/1 · Tablet, Film coated · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-344-26 | 51655034426 | 90 TABLET, FILM COATED in 1 BOTTLE (51655-344-26)Marketed from May 27, 2020 | |
| 51655-344-52 | 51655034452 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-344-52)Marketed from Aug 24, 2020 |
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, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203512
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 51655-344_48eb2ef1-10f5-aa75-e063-6294a90a901fSPL ID 48eb2ef1-10f5-aa75-e063-6294a90a901fSPL set ID ab3090fc-458c-17c1-e053-2995a90a6ffaRxCUI 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
N451655034426followed by a unit qualifier and the quantityPackage 51655-0344-26. 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 203512
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 | NuCare Pharmaceuticals,Inc. | 68071-4374 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-226 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-225 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-227 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0304 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-835 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-832 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0401 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-974 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3375 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-146 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-147 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-148 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-062 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-063 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0053 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3747 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-287 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-288 |