Spironolactone NDC 67544-310

NDC codes

FDA NDC Directory

Product NDC (as listed)67544-310Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67544-0310Add 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
67544-310-30	67544031030	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-30)Marketed from Dec 19, 2014
67544-310-45	67544031045	45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-45)Marketed from Sep 9, 2021
67544-310-60	67544031060	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (67544-310-60)Marketed from Dec 19, 2014

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, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040424
Marketing start: Feb 3, 1981
Listing expires: Dec 31, 2026
Other FDA classes: Aldosterone Antagonists (Mechanism)
Identifiers: Product ID 67544-310_3c92f359-98a1-43c4-b639-58ab3a388ab3SPL ID 3c92f359-98a1-43c4-b639-58ab3a388ab3SPL set ID 1c97ce61-8e49-4724-a636-d179479d346cRxCUI 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

N467544031030 followed by a unit qualifier and the quantity

Package 67544-0310-30. 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 Oct 14, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Spironolactone tablets are indicated in the management of: Primary Hyperaldosteronism for Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous Conditions for Patients with Congestive Heart Failure For the management of edema and sodium retention when the patient is o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040424

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

FDA NDC Directory listings under ANDA 040424
Product	Strength	Form · route	Labeler	Product NDC
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-089
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-087
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-088
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2150
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-979
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-980
Spironolactone	Spironolactone 50 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-0243
Spironolactone	Spironolactone 100 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-0437
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-5517
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-2146
Spironolactone	Spironolactone 25 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-103