Prescription drug · ANDA
Spironolactone NDC 82804-975
Spironolactone 25 mg/1 · Tablet, Coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-975-00 | 82804097500 | 100 TABLET, COATED in 1 BOTTLE (82804-975-00)Marketed from Feb 13, 2025 | |
| 82804-975-11 | 82804097511 | 1000 TABLET, COATED in 1 BOTTLE (82804-975-11)Marketed from Feb 13, 2025 | |
| 82804-975-30 | 82804097530 | 30 TABLET, COATED in 1 BOTTLE (82804-975-30)Marketed from Feb 13, 2025 | |
| 82804-975-55 | 82804097555 | 500 TABLET, COATED in 1 BOTTLE (82804-975-55)Marketed from Feb 13, 2025 | |
| 82804-975-60 | 82804097560 | 60 TABLET, COATED in 1 BOTTLE (82804-975-60)Marketed from Feb 13, 2025 | |
| 82804-975-72 | 82804097572 | 120 TABLET, COATED in 1 BOTTLE (82804-975-72)Marketed from Feb 13, 2025 | |
| 82804-975-90 | 82804097590 | 90 TABLET, COATED in 1 BOTTLE (82804-975-90)Marketed from Feb 13, 2025 |
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, Coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 82804-975_99b119e3-537a-464c-9376-4219bf283753SPL ID 99b119e3-537a-464c-9376-4219bf283753SPL set ID 99b119e3-537a-464c-9376-4219bf283753RxCUI 198222, 198223, 313096UNII 27O7W4T232UPC 0382804977307, 0382804975303, 0382804976300
- 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
N482804097500followed by a unit qualifier and the quantityPackage 82804-0975-00. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 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 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-0744 |
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