Spironolactone Suspension
NDC Package 69238-2027-2

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 suspension is spironolactone is used to treat high blood pressure and heart failure. This formulation utilizes a suspension delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-2027 and is authorized under FDA application ANDA215572.

Identification & Billing

NDC Package Code
69238-2027-2
Package Description
473 mL in 1 BOTTLE
Product Code
69238-2027
11-Digit Billing Format
69238202702
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Spironolactone
Non-Proprietary Name
Spironolactone
Substance Name
Spironolactone
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SPIRONOLACTONE 25 mg/5mL
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
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA215572
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-08-2023
Listing Expiration
12-31-2026
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 (69238-2027). Click a package code to view its specific billing and regulatory data.

69238-2027-8
118 mL in 1 BOTTLE

* 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 69238-2027-2 identifies a specific commercial package of 473 ml in 1 bottle of Spironolactone, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. This suspension 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 Amneal Pharmaceuticals Ny Llc on September 08, 2023. 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 Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238202702. 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)
69238-2027-2
11-Digit CMS (5-4-2)
69238-2027-02

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