Belbuca Film, Soluble
NDC Package 59385-024-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Belbuca (buprenorphine hydrochloride) films is buprenorphine is used to help relieve severe ongoing pain. This formulation utilizes a film, soluble delivery system. Marketed by Biodelivery Sciences International Inc, this product is identified by NDC 59385-024 and is authorized under FDA application NDA207932.

Identification & Billing

NDC Package Code
59385-024-60
Package Description
60 POUCH in 1 CARTON / 1 FILM, SOLUBLE in 1 POUCH (59385-024-01)
Product Code
59385-024
11-Digit Billing Format
59385002460
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Belbuca
Non-Proprietary Name
Buprenorphine Hydrochloride
Substance Name
Buprenorphine Hydrochloride
Dosage Form
Film, Soluble - A thin layer or coating which is susceptible to being dissolved when in contact with a liquid.
Administration Route
Buccal - Administration directed toward the cheek, generally from within the mouth.
Active Ingredient(s)
BUPRENORPHINE HYDROCHLORIDE 450 ug/1
Pharmacologic Class
Usage Information
Buprenorphine is used to help relieve severe ongoing pain. Buprenorphine belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use this medication to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Biodelivery Sciences International Inc
Product Type
Human Prescription Drug
FDA Application #
NDA207932
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-21-2017
Listing Expiration
12-31-2027
Exclude Flag
N
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 59385-024-60 identifies a specific commercial package of 60 pouch in 1 carton / 1 film, soluble in 1 pouch (59385-024-01) of Belbuca, a human prescription drug labeled by Biodelivery Sciences International Inc. This film, soluble is formulated for buccal use and contains buprenorphine hydrochloride 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 Biodelivery Sciences International Inc on August 21, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Buprenorphine is used to help relieve severe ongoing pain. Buprenorphine belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. Do not use this medication to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.

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: 59385002460. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
59385-024-60
11-Digit CMS (5-4-2)
59385-0024-60

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