Prescription drug · ANDA
Spironolactone NDC 71610-102
Spironolactone 25 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-102-60 | 71610010260 | 90 TABLET in 1 BOTTLE (71610-102-60)Marketed from Jul 26, 2018 |
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
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091426
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 71610-102_c9e366cc-e9b4-4e14-8c40-8daf2fe265adSPL ID c9e366cc-e9b4-4e14-8c40-8daf2fe265adSPL set ID bf58378f-8304-4799-b0c0-fad8697149abRxCUI 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
N471610010260followed by a unit qualifier and the quantityPackage 71610-0102-60. 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 091426
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 | TabletOral | Bryant Ranch Prepack | 71335-0966 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | PharmPak, Inc. | 54348-340 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-514 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-511 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-515 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | QPharma, Inc | 42708-126 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-511 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-514 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-515 |