Buprenorphine
NDC Package 0093-3602-40

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.

Buprenorphine is a medication used to help relieve severe ongoing pain (such as due to arthritis, chronic back pain). Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0093-3602 and is authorized under FDA application NDA021306.

Identification & Billing

NDC Package Code
0093-3602-40
Package Description
4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0093-3602-21) / 168 h in 1 PATCH
Product Code
0093-3602
11-Digit Billing Format
00093360240
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

Clinical Specifications

Proprietary Name
Buprenorphine
Dosage Form
-
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.

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
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
05-30-2017
End Marketing Date
07-31-2019
Listing Expiration
07-31-2019
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 0093-3602-40 identifies a specific commercial package of 4 pouch in 1 carton / 1 patch in 1 pouch (0093-3602-21) / 168 h in 1 patch of Buprenorphine, labeled by Teva Pharmaceuticals Usa, 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 Teva Pharmaceuticals Usa, Inc. on May 30, 2017. The current certification is valid through July 31, 2019.

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 Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00093360240. 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 (4-4-2)
0093-3602-40
11-Digit CMS (5-4-2)
00093-3602-40

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