Prescription drug · ANDA
Spironolactone NDC 69238-2027
Spironolactone 25 mg/5mL · Suspension · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2027-2 | 69238202702 | 473 mL in 1 BOTTLE (69238-2027-2)Marketed from Sep 8, 2023 | |
| 69238-2027-8 | 69238202708 | 118 mL in 1 BOTTLE (69238-2027-8)Marketed from Sep 8, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/5mL
- Dosage form
- Suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215572
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 69238-2027_e25b36dd-7948-4481-8994-13658f1f337fSPL ID e25b36dd-7948-4481-8994-13658f1f337fSPL set ID 1ed9a2cb-d666-43db-b515-f9615fa6da25RxCUI 104232UNII 27O7W4T232UPC 0369238202786
- 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
N469238202702followed by a unit qualifier and the quantityPackage 69238-2027-02. 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 oral suspension is an antagonist of aldosterone 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 cirrhotic patients when edema is not responsive to fluid and sodium restrictions (1.3) 1.1 Heart Failure Spironolactone oral suspension is indicated for treatment of NYHA Class III-IV h…
Excerpt only. Read the full label for complete information.