Prescription drug · ANDA
Spironolactone NDC 72603-135
Spironolactone 50 mg/1 · Tablet · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-135-01 | 72603013501 | 100 TABLET in 1 BOTTLE (72603-135-01)Marketed from Dec 13, 2019 | |
| 72603-135-02 | 72603013502 | 500 TABLET in 1 BOTTLE (72603-135-02)Marketed from Dec 13, 2019 |
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
- Route
- Oral
- Labeler
- NorthStar Rx LLC
- 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 72603-135_04da3e98-02e5-4d5a-94b2-9a6f74c44f15SPL ID 04da3e98-02e5-4d5a-94b2-9a6f74c44f15SPL set ID ae0dcb4e-63df-459c-8e60-0caa817b8135RxCUI 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
N472603013501followed by a unit qualifier and the quantityPackage 72603-0135-01. 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
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 sod…
Excerpt only. Read the full label for complete information.
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 50 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3795 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Redpharm Drug | 67296-2319 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4447 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2989 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2988 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3903 |
| 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 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-427 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-426 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-428 |
| 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 100 mg/1 | TabletOral | NorthStar Rx LLC | 72603-136 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | NorthStar Rx LLC | 72603-134 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Redpharm Drug | 67296-2285 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6908 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6909 |