Prescription drug · ANDA
Spironolactone NDC 76420-926
Spironolactone 50 mg/1 · Tablet, Coated · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-926-00 | 7642009260076420092600 | 1000 TABLET, COATED in 1 BOTTLE (76420-926-00)Marketed from Mar 6, 2025 | |
| 76420-926-01 | 7642009260176420092601 | 100 TABLET, COATED in 1 BOTTLE (76420-926-01)Marketed from Mar 6, 2025 | |
| 76420-926-05 | 7642009260576420092605 | 500 TABLET, COATED in 1 BOTTLE (76420-926-05)Marketed from Mar 6, 2025 | |
| 76420-926-30 | 7642009263076420092630 | 30 TABLET, COATED in 1 BOTTLE (76420-926-30)Marketed from Mar 6, 2025 | |
| 76420-926-60 | 7642009266076420092660 | 60 TABLET, COATED in 1 BOTTLE (76420-926-60)Marketed from Mar 6, 2025 | |
| 76420-926-90 | 7642009269076420092690 | 90 TABLET, COATED in 1 BOTTLE (76420-926-90)Marketed from Mar 6, 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 — 50 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- 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 76420-926_2fa991e8-8594-6911-e063-6294a90a916dSPL ID 2fa991e8-8594-6911-e063-6294a90a916dSPL set ID db22e9e5-2d88-4712-a809-c00881edb447RxCUI 198222, 198223, 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
N476420092600followed by a unit qualifier and the quantityPackage 76420-0926-00. 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
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.
About NDC 76420-926
- What is NDC 76420-926?
- 76420-926 is the product NDC for Spironolactone, Spironolactone 50 mg/1 tablet, coated, listed with the FDA by Asclemed USA, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Spironolactone.
- What is the active ingredient?
- Spironolactone.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Spironolactone?
- 177 other product NDCs are listed under this name. See all Spironolactone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Spironolactone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4188 | 68788-4188-0368788-4188-0668788-4188-09 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-0613 | 67046-0613-03 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-0744 | 67046-0744-03 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-087 | 48433-0087-20 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-088 | 48433-0088-20 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-089 | 48433-0089-08 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1636 | 67046-1636-03 |
| spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4512 | 70518-4512-0070518-4512-02 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-706 | 64980-0706-0164980-0706-50 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-707 | 64980-0707-0164980-0707-50 |
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 25 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-6369 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-6458 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-6539 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-6600 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-7797 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-041 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-0613 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-0744 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1636 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals, Inc. | 68071-3967 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-3969 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals, Inc | 68788-8381 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-8452 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-8545 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Oxford Pharmaceuticals, LLC | 69584-852 |
| 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 | REMEDYREPACK INC. | 70518-3625 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-3655 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-3721 |
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