Spironolactone Tablet, Film Coated
NDC Package 67544-310-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Spironolactone tablets is spironolactone is used to treat high blood pressure and heart failure. This formulation utilizes a tablet, film coated delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 67544-310 and is authorized under FDA application ANDA040424.

Identification & Billing

NDC Package Code
67544-310-60
Package Description
90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
67544-310
11-Digit Billing Format
67544031060
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA
RxNorm Crosswalk
RxCUI: 313096 - spironolactone 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Spironolactone
Non-Proprietary Name
Spironolactone
Substance Name
Spironolactone
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SPIRONOLACTONE 25 mg/1
Pharmacologic Class
Usage Information
Spironolactone is used to treat high blood pressure and heart failure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to treat swelling (edema) caused by certain conditions (such as heart failure, liver disease) by removing excess fluid and improving symptoms such as breathing problems. This medication is also used to treat conditions in which the body is making too much of a natural substance (aldosterone). Spironolactone is known as a "water pill" (potassium-sparing diuretic).

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA040424
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-03-1981
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67544-310). Click a package code to view its specific billing and regulatory data.

67544-310-30
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
67544-310-45
45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67544-310-60 identifies a specific commercial package of 90 tablet, film coated in 1 bottle, plastic of Spironolactone, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. This tablet, film coated is formulated for oral use and contains spironolactone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Aphena Pharma Solutions - Tennessee, Llc on February 03, 1981. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Spironolactone is used to treat high blood pressure and heart failure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to treat swelling (edema) caused by certain conditions (such as heart failure, liver disease) by removing excess fluid and improving symptoms such as breathing problems. This medication is also used to treat conditions in which the body is making too much of a natural substance (aldosterone). Spironolactone is known as a "water pill" (potassium-sparing diuretic).

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67544031060. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
67544-310-60
11-Digit CMS (5-4-2)
67544-0310-60

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.