Suboxone
NDC Package 54868-5707-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Suboxone is this medication contains 2 medicines: buprenorphine and naloxone. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5707 and is authorized under FDA application NDA020733.

Identification & Billing

NDC Package Code
54868-5707-2
Package Description
14 TABLET in 1 BOTTLE
Product Code
11-Digit Billing Format
54868570702
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
14 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Suboxone
Dosage Form
-
Usage Information
This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat opioid dependence/addiction. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opioids. Naloxone is an opioid antagonist that blocks the effect of opioids and can cause severe opioid withdrawal when injected. Withdrawal is less likely when naloxone is taken by mouth, dissolved under the tongue, or dissolved on the inside of the cheek. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA020733
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-07-2008
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-5707). Click a package code to view its specific billing and regulatory data.

30 TABLET in 1 BOTTLE
21 TABLET in 1 BOTTLE
28 TABLET in 1 BOTTLE
7 TABLET in 1 BOTTLE

* 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 54868-5707-2 identifies a specific commercial package of 14 tablet in 1 bottle of Suboxone, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 14 billable units per package. 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 Physicians Total Care, Inc. on July 07, 2008. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat opioid dependence/addiction. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opioids. Naloxone is an opioid antagonist that blocks the effect of opioids and can cause severe opioid withdrawal when injected. Withdrawal is less likely when naloxone is taken by mouth, dissolved under the tongue, or dissolved on the inside of the cheek. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868570702. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 14 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)
54868-5707-2
11-Digit CMS (5-4-2)
54868-5707-02

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