Eplerenone Tablet, Coated
NDC Package 71335-2355-2

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

Eplerenone tablets is a medication used alone or in combination with other medicines to treat high blood pressure. This formulation utilizes a tablet, coated delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 71335-2355 and is authorized under FDA application ANDA207842.

Identification & Billing

NDC Package Code
71335-2355-2
Package Description
30 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
71335-2355
11-Digit Billing Format
71335235502
RxNorm Crosswalk
RxCUI: 351256 - eplerenone 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Eplerenone
Non-Proprietary Name
Eplerenone
Substance Name
Eplerenone
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)
EPLERENONE 25 mg/1
Pharmacologic Class
Usage Information
This medication is used alone or in combination with other medicines to treat high blood pressure. It works by blocking a chemical (aldosterone) in your body which in turn lowers the amount of sodium and water the body retains. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. It is also used to treat congestive heart failure following a heart attack.

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA207842
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-08-2021
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 (71335-2355). Click a package code to view its specific billing and regulatory data.

71335-2355-1
90 TABLET, 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 71335-2355-2 identifies a specific commercial package of 30 tablet, coated in 1 bottle, plastic of Eplerenone, a human prescription drug labeled by Bryant Ranch Prepack. This tablet, coated is formulated for oral use and contains eplerenone 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 Bryant Ranch Prepack on November 08, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used alone or in combination with other medicines to treat high blood pressure. It works by blocking a chemical (aldosterone) in your body which in turn lowers the amount of sodium and water the body retains. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. It is also used to treat congestive heart failure following a heart attack.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71335235502. 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)
71335-2355-2
11-Digit CMS (5-4-2)
71335-2355-02

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