Buprenorphine Patch, Extended Release
NDC Package 69238-1204-2

11-digit billing NDC: 69238120402 · Billing unit: EA · 4 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Buprenorphine patches is buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic. This formulation utilizes a patch, extended release delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 69238-1204 and is authorized under FDA application ANDA211586.

Identification & Billing

NDC Package Code
69238-1204-2
Package Description
4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 168 h in 1 PATCH
Product Code
69238-1204
11-Digit Billing Format
69238120402
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Buprenorphine
Non-Proprietary Name
Buprenorphine
Substance Name
Buprenorphine
Dosage Form
Patch, Extended Release - A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
BUPRENORPHINE 15 ug/h
Pharmacologic Class
Usage Information
Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211586
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-20-2020
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 69238-1204-2 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 Amneal Pharmaceuticals Ny Llc. This patch, extended release 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 Amneal Pharmaceuticals Ny Llc on April 20, 2020. The current certification is valid through December 31, 2027.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69238120402. 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 (5-4-1)
69238-1204-2
11-Digit CMS (5-4-2)
69238-1204-02

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