Spironolactone Tablet, Coated
NDC Package 82804-976-55

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, coated delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 82804-976 and is authorized under FDA application ANDA040750.

Identification & Billing

NDC Package Code
82804-976-55
Package Description
500 TABLET, COATED in 1 BOTTLE
Product Code
82804-976
11-Digit Billing Format
82804097655
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
500 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Spironolactone
Non-Proprietary Name
Spironolactone
Substance Name
Spironolactone
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SPIRONOLACTONE 50 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
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
ANDA040750
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-04-2021
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 (82804-976). Click a package code to view its specific billing and regulatory data.

82804-976-00
100 TABLET, COATED in 1 BOTTLE
82804-976-11
1000 TABLET, COATED in 1 BOTTLE
82804-976-30
30 TABLET, COATED in 1 BOTTLE
82804-976-60
60 TABLET, COATED in 1 BOTTLE
82804-976-72
120 TABLET, COATED in 1 BOTTLE
82804-976-90
90 TABLET, COATED 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 82804-976-55 identifies a specific commercial package of 500 tablet, coated in 1 bottle of Spironolactone, a human prescription drug labeled by Proficient Rx Lp. This product is billed for "EA" each discreet unit and contains an estimated amount of 500 billable units per package. This tablet, 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 Proficient Rx Lp on January 04, 2021. 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 Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82804097655. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 500 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)
82804-976-55
11-Digit CMS (5-4-2)
82804-0976-55

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