Buprenorphine Patch
NDC Package 42858-839-40

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

Package Information

Buprenorphine patches is a medication used to help relieve severe ongoing pain (such as due to arthritis, chronic back pain). This formulation utilizes a patch delivery system. Marketed by Rhodes Pharmaceuticals Llc, this product is identified by NDC 42858-839 and is authorized under FDA application NDA021306.

Identification & Billing

NDC Package Code
42858-839-40
Package Description
4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 168 h in 1 PATCH
Product Code
42858-839
11-Digit Billing Format
42858083940
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Buprenorphine
Non-Proprietary Name
Buprenorphine
Substance Name
Buprenorphine
Dosage Form
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
BUPRENORPHINE 20 ug/h
Pharmacologic Class
Usage Information
This medication is used to help relieve severe ongoing pain (such as due to arthritis, chronic back 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. The higher strengths of this drug (7.5, 10, 15, or 20 micrograms per hour patches) should be used only if you have been regularly taking moderate amounts of opioid pain medication. These strengths may cause overdose (even death) if used by a person who has not been regularly taking opioids. 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
Rhodes Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021306
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
07-03-2017
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 42858-839-40 identifies a specific commercial package of 4 pouch in 1 carton / 1 patch in 1 pouch / 168 h in 1 patch of Buprenorphine, a human prescription drug labeled by Rhodes Pharmaceuticals Llc. This patch is formulated for transdermal use and contains buprenorphine 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 Rhodes Pharmaceuticals Llc on July 03, 2017. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to help relieve severe ongoing pain (such as due to arthritis, chronic back 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. The higher strengths of this drug (7.5, 10, 15, or 20 micrograms per hour patches) should be used only if you have been regularly taking moderate amounts of opioid pain medication. These strengths may cause overdose (even death) if used by a person who has not been regularly taking opioids. 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 Rhodes Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42858083940. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
42858-839-40
11-Digit CMS (5-4-2)
42858-0839-40

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