Prescription drug · NDA AUTHORIZED GENERIC
Spironolactone NDC 17856-1133
Spironolactone 25 mg/5mL · Suspension · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-1133-1 | 17856113301 | 1 SYRINGE in 1 BAG (17856-1133-1) / 2.5 mL in 1 SYRINGE (17856-1133-3)Marketed from Jun 3, 2024 | |
| 17856-1133-4 | 17856113304 | 1 SYRINGE in 1 BAG (17856-1133-4) / 2.5 mL in 1 SYRINGE (17856-1133-2)Marketed from Sep 26, 2025 | |
| 17856-1133-5 | 17856113305 | 120 SYRINGE in 1 CASE (17856-1133-5) / 1 mL in 1 SYRINGEMarketed from Apr 30, 2026 | |
| 17856-1133-6 | 17856113306 | 120 SYRINGE in 1 CASE (17856-1133-6) / 3 mL in 1 SYRINGEMarketed from Apr 30, 2026 | |
| 17856-1133-7 | 17856113307 | 1 SYRINGE in 1 BAG (17856-1133-7) / 1 mL in 1 SYRINGEMarketed from Jul 2, 2026 | |
| 17856-1133-8 | 17856113308 | 1 SYRINGE in 1 BAG (17856-1133-8) / 3 mL in 1 SYRINGEMarketed from Jul 2, 2026 |
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
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 209478
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 17856-1133_59f7927f-899d-3af9-e063-6394a90aacbdSPL ID 59f7927f-899d-3af9-e063-6394a90aacbdSPL set ID 122558a0-57bb-4195-9adf-d37b049cbfb5RxCUI 104232UNII 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
N417856113301followed by a unit qualifier and the quantityPackage 17856-1133-01. 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 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 II…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 209478
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/5mL | SuspensionOral | Atlantic Biologicals Corp. | 17856-1233 |
| Spironolactone | Spironolactone 25 mg/5mL | SuspensionOral | Padagis US LLC | 0574-1133 |
| CaroSpir | Spironolactone 25 mg/5mL | SuspensionOral | CMP Pharma, Inc. | 46287-020 |