Oleptro
NDC Package 43595-080-03

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 discontinued by the firm.

Oleptro is a . Marketed by Angelini Pharma Inc., this product is identified by NDC 43595-080 and is authorized under FDA application NDA022411.

Identification & Billing

NDC Package Code
43595-080-03
Package Description
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
43595-080
11-Digit Billing Format
43595008003
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA

Clinical Specifications

Proprietary Name
Oleptro
Dosage Form
-

Regulatory & Marketing

Labeler Name
Angelini Pharma Inc.
FDA Application #
NDA022411
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-02-2010
End Marketing Date
02-29-2016
Listing Expiration
02-29-2016
Exclude Flag
D
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 43595-080-03 identifies a specific commercial package of 30 tablet, extended release in 1 bottle of Oleptro, labeled by Angelini Pharma Inc.. 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 Angelini Pharma Inc. on February 02, 2010. The current certification is valid through February 29, 2016.

How is this Angelini Pharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43595008003. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
43595-080-03
11-Digit CMS (5-4-2)
43595-0080-03

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