Transmucosal Fentanyl Citrate
NDC Package 52959-548-30

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 inactivated by the FDA.

Transmucosal Fentanyl Citrate is oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Marketed by H.j. Harkins Company, Inc., this product is identified by NDC 52959-548 and is authorized under FDA application NDA020747.

Identification & Billing

NDC Package Code
52959-548-30
Package Description
30 BLISTER PACK in 1 CARTON / 1 LOZENGE in 1 BLISTER PACK (52959-548-01)
Product Code
52959-548
11-Digit Billing Format
52959054830
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Transmucosal Fentanyl Citrate
Dosage Form
-
Usage Information
Oral Transmucosal Fentanyl Citrate (OTFC) is indicated only for the management of breakthrough cancer pain in patients 16 and older with malignancies who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when taking OTFC.This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, OTFC is contraindicated in the management of acute or postoperative pain.OTFC is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.

Regulatory & Marketing

Labeler Name
H.j. Harkins Company, Inc.
FDA Application #
NDA020747
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-06-2006
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 52959-548-30 identifies a specific commercial package of 30 blister pack in 1 carton / 1 lozenge in 1 blister pack (52959-548-01) of Transmucosal Fentanyl Citrate, labeled by H.j. Harkins Company, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 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 H.j. Harkins Company, Inc. on September 06, 2006. The current certification is valid through December 31, 2017.

How is this H.j. Harkins Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52959054830. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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 (5-3-2)
52959-548-30
11-Digit CMS (5-4-2)
52959-0548-30

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