Bunavail
NDC Package 59385-014-30

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.

Bunavail is this medication contains 2 medicines: buprenorphine and naloxone. Marketed by Biodelivery Sciences International, Inc., this product is identified by NDC 59385-014 and is authorized under FDA application NDA205637.

Identification & Billing

NDC Package Code
59385-014-30
Package Description
30 POUCH in 1 BOX / 1 FILM in 1 POUCH (59385-014-01)
Product Code
59385-014
11-Digit Billing Format
59385001430
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
Bunavail
Dosage Form
-
Usage Information
This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat opioid dependence/addiction. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opioids. Naloxone is an opioid antagonist that blocks the effect of opioids and can cause severe opioid withdrawal when injected. Withdrawal is less likely when naloxone is taken by mouth. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication 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
Biodelivery Sciences International, Inc.
FDA Application #
NDA205637
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-30-2014
End Marketing Date
10-31-2021
Listing Expiration
10-31-2021
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 59385-014-30 identifies a specific commercial package of 30 pouch in 1 box / 1 film in 1 pouch (59385-014-01) of Bunavail, labeled by Biodelivery Sciences International, 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 Biodelivery Sciences International, Inc. on September 30, 2014. The current certification is valid through October 31, 2021.

What are the primary indications for this medication?

This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat opioid dependence/addiction. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opioids. Naloxone is an opioid antagonist that blocks the effect of opioids and can cause severe opioid withdrawal when injected. Withdrawal is less likely when naloxone is taken by mouth. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

How is this Biodelivery Sciences International, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59385001430. 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)
59385-014-30
11-Digit CMS (5-4-2)
59385-0014-30

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