Eplerenone Micronized Powder
NDC Package 63190-0750-5

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

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Eplerenone Micronized powders is a medication used alone or in combination with other medicines to treat high blood pressure. This formulation utilizes a powder delivery system. Marketed by Industriale Chimica S.r.l., this product is identified by NDC 63190-0750.

Identification & Billing

NDC Package Code
63190-0750-5
Package Description
1 kg in 1 DRUM
Product Code
63190-0750
11-Digit Billing Format
63190075005

Clinical Specifications

Proprietary Name
Eplerenone Micronized
Non-Proprietary Name
Eplerenone Micronized
Substance Name
Eplerenone
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
EPLERENONE 1 kg/kg
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
Industriale Chimica S.r.l.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-08-2006
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 (63190-0750). Click a package code to view its specific billing and regulatory data.

63190-0750-3
30 kg in 1 DRUM

* 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 63190-0750-5 identifies a specific commercial package of 1 kg in 1 drum of Eplerenone Micronized (UNFINISHED drug), a bulk ingredient labeled by Industriale Chimica S.r.l.. This powder is formulated for 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 Industriale Chimica S.r.l. on September 08, 2006. 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 Industriale Chimica S.r.l. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63190075005. 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)
63190-0750-5
11-Digit CMS (5-4-2)
63190-0750-05

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