Prescription drug · ANDA
Spironolactone NDC 71610-742
Spironolactone 25 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-742-30 | 71610074230 | 30 TABLET in 1 BOTTLE, PLASTIC (71610-742-30)Marketed from Oct 26, 2023 | |
| 71610-742-45 | 71610074245 | 45 TABLET in 1 BOTTLE, PLASTIC (71610-742-45)Marketed from Oct 10, 2023 | |
| 71610-742-60 | 71610074260 | 90 TABLET in 1 BOTTLE, PLASTIC (71610-742-60)Marketed from Oct 10, 2023 | |
| 71610-742-80 | 71610074280 | 180 TABLET in 1 BOTTLE, PLASTIC (71610-742-80)Marketed from Oct 10, 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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089424
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 71610-742_affa2e96-25b1-435b-9668-82dcd7a5777eSPL ID affa2e96-25b1-435b-9668-82dcd7a5777eSPL set ID fb961096-edbb-45ad-96b7-61c2f9b98cf9RxCUI 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
N471610074230followed by a unit qualifier and the quantityPackage 71610-0742-30. 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 .
Indications (excerpt from the label)
Spironolactone tablets are 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 fl…
Excerpt only. Read the full label for complete information.
About NDC 71610-742
- What is NDC 71610-742?
- 71610-742 is the product NDC for Spironolactone, Spironolactone 25 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?
- 171 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 089424
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 | A-S Medication Solutions | 50090-0136 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6408 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6432 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 53489-143 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 53489-328 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 53489-329 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1061 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1062 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1064 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1065 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1066 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1067 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1094 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1830 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4094 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-5341 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8539 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4188 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4350 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Proficient Rx LP | 71205-772 |
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