Prescription drug · ANDA
Spironolactone NDC 71205-146
Spironolactone 25 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-146-30 | 71205014630 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-146-30)Marketed from Nov 1, 2018 | |
| 71205-146-60 | 71205014660 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-146-60)Marketed from Nov 1, 2018 | |
| 71205-146-90 | 71205014690 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-146-90)Marketed from Nov 1, 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, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 71205-146_5857334b-cd0a-47c8-ba29-b8ba367162faSPL ID 5857334b-cd0a-47c8-ba29-b8ba367162faSPL set ID dffac5dc-a111-4095-a96c-54cc5c3866e5RxCUI 198222, 198223, 313096UNII 27O7W4T232UPC 0371205148300, 0371205147303, 0371205146306
- 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
N471205014630followed by a unit qualifier and the quantityPackage 71205-0146-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Spironolactone tablets are indicated in the management of: Primary hyperaldosteronism for: Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with: Congestive heart failure: For the management of edema and sodium retention when the patient is…
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 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 | Northwind Health Company, LLC | 51655-344 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-288 |