Spironolactone
NDC Package 17856-2028-3

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Spironolactone is used to treat high blood pressure and heart failure. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-2028 and is authorized under FDA application ANDA215572.

Identification & Billing

NDC Package Code
17856-2028-3
Package Description
60 SYRINGE in 1 PACKAGE / 10 SYRINGE in 1 SYRINGE (17856-2028-2) / 2.5 mL in 1 SYRINGE (17856-2028-1)
Product Code
17856-2028
11-Digit Billing Format
17856202803
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Spironolactone
Dosage Form
-
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
Atlantic Biologicals Corp.
FDA Application #
ANDA215572
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-08-2023
Listing Expiration
12-31-2025
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 17856-2028-3 identifies a specific commercial package of 60 syringe in 1 package / 10 syringe in 1 syringe (17856-2028-2) / 2.5 ml in 1 syringe (17856-2028-1) of Spironolactone, labeled by Atlantic Biologicals Corp.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Atlantic Biologicals Corp. on September 08, 2023. The current certification is valid through December 31, 2025.

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 Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856202803. 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 (5-4-1)
17856-2028-3
11-Digit CMS (5-4-2)
17856-2028-03

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