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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 |