Fentanyl
NDC Package 54868-0162-1

11-digit billing NDC: 54868016201 · Billing unit: EA · 10 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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

Fentanyl is transdermal system is indicated for management of persistent, moderate to severe chronic pain that: requires continuous, around-the-clock opioid administration for an extended period of time, andcannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioidsFentanyl transdermal system should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr (see DOSAGE AND ADMINISTRATION). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-0162 and is authorized under FDA application ANDA076258.

Identification & Billing

NDC Package Code
54868-0162-1
Package Description
10 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 72 [USP'U] in 1 PATCH
Product Code
54868-0162
11-Digit Billing Format
54868016201
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fentanyl
Dosage Form
-
Usage Information
Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that: requires continuous, around-the-clock opioid administration for an extended period of time, andcannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioidsFentanyl transdermal system should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr (see DOSAGE AND ADMINISTRATION). Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.Because serious or life-threatening hypoventilation could result, fentanyl transdermal system is contraindicated for use on an as needed basis (i.e., prn), for the management of postoperative or acute pain, or in patients who are not opioid-tolerant or who require opioid analgesia for a short period of time (see BOX WARNING and CONTRAINDICATIONS).An evaluation of the appropriateness and adequacy of treating with immediate-release opioids is advisable prior to initiating therapy with any modified-release opioid. Prescribers should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen, to opioids, in a plan of pain management such as outlined by the World Health Organization, the Agency for Health Research and Quality, the Federation of State Medical Boards Model Policy, or the American Pain Society.Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. Patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA076258
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-14-2005
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 (54868-0162). Click a package code to view its specific billing and regulatory data.

54868-0162-0
5 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 72 [USP'U] in 1 PATCH

* 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 54868-0162-1 identifies a specific commercial package of 10 pouch in 1 carton / 1 patch in 1 pouch / 72 [usp'u] in 1 patch of Fentanyl, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 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 14, 2005. The current certification is valid through December 31, 2017.

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: 54868016201. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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)
54868-0162-1
11-Digit CMS (5-4-2)
54868-0162-01

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