Prescription drug · ANDA
Spironolactone NDC 42708-126
Spironolactone 25 mg/1 · Tablet · Oral · QPharma, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42708-126-30 | 4270801263042708012630 | 30 TABLET in 1 BOTTLE (42708-126-30)Marketed from May 23, 2018 · Sample package |
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
- QPharma, IncNDC labeler code 42708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091426
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 42708-126_5190401f-30e9-5394-e063-6294a90ab09bSPL ID 5190401f-30e9-5394-e063-6294a90ab09bSPL set ID eb314e91-6dd5-4bdb-af35-5d147b20339cRxCUI 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
N442708012630followed by a unit qualifier and the quantityPackage 42708-0126-30. 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 42708-126
- What is NDC 42708-126?
- 42708-126 is the product NDC for Spironolactone, Spironolactone 25 mg/1 tablet, listed with the FDA by QPharma, Inc. It has 1 package NDC, 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?
- QPharma, Inc, NDC labeler code 42708. 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 091426
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 | Amneal Pharmaceuticals of New York LLC | 53746-511 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-514 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-515 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | PharmPak, Inc. | 54348-340 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-511 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-514 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-515 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0966 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-102 |