Buprenorphine Hydrochloride
NDC Package 0517-0725-05

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.

Buprenorphine Hydrochloride is a . Marketed by American Regent, Inc., this product is identified by NDC 0517-0725 and is authorized under FDA application ANDA078331.

Identification & Billing

NDC Package Code
0517-0725-05
Package Description
5 VIAL in 1 CARTON / 1 mL in 1 VIAL (0517-0725-01)
Product Code
0517-0725
11-Digit Billing Format
00517072505

Clinical Specifications

Proprietary Name
Buprenorphine Hydrochloride
Dosage Form
-

Regulatory & Marketing

Labeler Name
American Regent, Inc.
FDA Application #
ANDA078331
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-13-2010
End Marketing Date
06-30-2012
Listing Expiration
06-30-2012
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 0517-0725-05 identifies a specific commercial package of 5 vial in 1 carton / 1 ml in 1 vial (0517-0725-01) of Buprenorphine Hydrochloride, labeled by American Regent, 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 American Regent, Inc. on August 13, 2010. The current certification is valid through June 30, 2012.

How is this American Regent, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00517072505. 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 (4-4-2)
0517-0725-05
11-Digit CMS (5-4-2)
00517-0725-05

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