Prescription drug · ANDA
Spironolactone NDC 59651-428
Spironolactone 100 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-428-01 | 5965104280159651042801 | 100 TABLET in 1 BOTTLE (59651-428-01)Marketed from Dec 13, 2019 | |
| 59651-428-05 | 5965104280559651042805 | 500 TABLET in 1 BOTTLE (59651-428-05)Marketed from Aug 24, 2023 |
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
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202187
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 59651-428_81936486-134f-439a-aa35-99fe0afdc9c5SPL ID 81936486-134f-439a-aa35-99fe0afdc9c5
- 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
N459651042801followed by a unit qualifier and the quantityPackage 59651-0428-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 59651-428
- What is NDC 59651-428?
- 59651-428 is the product NDC for Spironolactone, Spironolactone 100 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 202187
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 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8451 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8452 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6908 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6909 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7082 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7083 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-426 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-427 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Redpharm Drug | 67296-2285 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Redpharm Drug | 67296-2319 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2988 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2989 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3795 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3903 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4447 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2681 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2682 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2683 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | NorthStar Rx LLC | 72603-134 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | NorthStar Rx LLC | 72603-135 |
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