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  5. NDC Package Code: 52959-549-30 Transmucosal Fentanyl Citrate

NDC Package 52959-549-30 Transmucosal Fentanyl Citrate

View Billable Units, 11-Digit Format, RxNorm

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.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
52959-549-30
Package Description:
30 BLISTER PACK in 1 CARTON / 1 LOZENGE in 1 BLISTER PACK (52959-549-01)
Product Code:
52959-549
Proprietary Name:
Transmucosal Fentanyl Citrate
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.
11-Digit NDC Billing Format:
52959054930
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 310293 - fentaNYL citrate 1200 MCG Oral Lozenge
  • RxCUI: 310293 - fentanyl 1.2 MG Oral Lozenge
  • RxCUI: 310293 - fentanyl (as fentanyl citrate) 1200 MCG Oral Lozenge
  • RxCUI: 310297 - fentaNYL citrate 400 MCG Oral Lozenge
  • RxCUI: 310297 - fentanyl 0.4 MG Oral Lozenge
    • Labeler Name:
    H.j. Harkins Company, Inc.
    Sample Package:
    No
    Start Marketing Date:
    09-06-2006
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    I
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 52959-549-30?

    The NDC Packaged Code 52959-549-30 is assigned to a package of 30 blister pack in 1 carton / 1 lozenge in 1 blister pack (52959-549-01) of Transmucosal Fentanyl Citrate, labeled by H.j. Harkins Company, Inc.. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package.

    Is NDC 52959-549 included in the NDC Directory?

    No, Transmucosal Fentanyl Citrate with product code 52959-549 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by H.j. Harkins Company, Inc. on September 06, 2006 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 52959-549-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 52959-549-30?

    The 11-digit format is 52959054930. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-252959-549-305-4-252959-0549-30