Spironolactone NDC 0574-1133

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-1133Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-1133Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0574-1133-04	00574113304	118 mL in 1 BOTTLE (0574-1133-04)Marketed from Oct 31, 2023
0574-1133-10	00574113310	10 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10) / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05)Marketed from Oct 31, 2023
0574-1133-16	00574113316	473 mL in 1 BOTTLE (0574-1133-16)Marketed from Oct 31, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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/5mL
Dosage form: Suspension
Route: Oral
Labeler: Padagis US LLC
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 209478
Marketing start: Oct 31, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Aldosterone Antagonists (Mechanism)
Identifiers: Product ID 0574-1133_902035fb-dba8-4fdf-9d8d-29d736c07d57SPL ID 902035fb-dba8-4fdf-9d8d-29d736c07d57SPL set ID 522bd365-ddcc-48f4-8a98-66dc4c3bb314RxCUI 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

N400574113304 followed by a unit qualifier and the quantity

Package 00574-1133-04. 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 Jan 1, 2025.

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 Cl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 209478

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 209478
Product	Strength	Form · route	Labeler	Product NDC
Spironolactone	Spironolactone 25 mg/5mL	SuspensionOral	ATLANTIC BIOLOGICALS CORP.	17856-1133
Spironolactone	Spironolactone 25 mg/5mL	SuspensionOral	Atlantic Biologicals Corp.	17856-1233
CaroSpir	Spironolactone 25 mg/5mL	SuspensionOral	CMP Pharma, Inc.	46287-020