Probuphine
NDC Package 58284-100-14

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.

Probuphine is buprenorphine is used to treat opioid dependence/addiction. Marketed by Braeburn Pharmaceuticals, this product is identified by NDC 58284-100 and is authorized under FDA application NDA204442.

Identification & Billing

NDC Package Code
58284-100-14
Package Description
4 POUCH in 1 CARTON / 1 IMPLANT in 1 POUCH
Product Code
58284-100
11-Digit Billing Format
58284010014
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA

Clinical Specifications

Proprietary Name
Probuphine
Dosage Form
-
Usage Information
Buprenorphine is used to treat opioid dependence/addiction. Buprenorphine belongs to a class of drugs known as mixed opioid agonist-antagonists. It helps prevent withdrawal symptoms caused by stopping other opioids. It is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

Regulatory & Marketing

Labeler Name
Braeburn Pharmaceuticals
FDA Application #
NDA204442
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-09-2016
End Marketing Date
04-02-2019
Listing Expiration
04-02-2019
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 58284-100-14 identifies a specific commercial package of 4 pouch in 1 carton / 1 implant in 1 pouch of Probuphine, labeled by Braeburn Pharmaceuticals. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. 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 Braeburn Pharmaceuticals on June 09, 2016. The current certification is valid through April 02, 2019.

What are the primary indications for this medication?

Buprenorphine is used to treat opioid dependence/addiction. Buprenorphine belongs to a class of drugs known as mixed opioid agonist-antagonists. It helps prevent withdrawal symptoms caused by stopping other opioids. It is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

How is this Braeburn Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58284010014. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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)
58284-100-14
11-Digit CMS (5-4-2)
58284-0100-14

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