Buprenorphine Patch, Extended Release
NDC Package 3215-1521-04

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, extended release delivery system. Marketed by Aveva Drug Delivery Systems Inc., this product is identified by NDC 3215-1521 and is authorized under FDA application ANDA210272.

Identification & Billing

NDC Package Code
3215-1521-04
Package Description
4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 168 h in 1 PATCH
Product Code
3215-1521
11-Digit Billing Format
03215152104
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 5 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
Aveva Drug Delivery Systems Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210272
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2023
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 3215-1521-04 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 Aveva Drug Delivery Systems Inc.. 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 Aveva Drug Delivery Systems Inc. on November 01, 2023. 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 Aveva Drug Delivery Systems Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 03215152104. 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 (4-4-2)
3215-1521-04
11-Digit CMS (5-4-2)
03215-1521-04

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