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  5. NDC Package Code: 63459-541-28 Fentora

NDC Package 63459-541-28 Fentora

Fentanyl Tablet Buccal; Sublingual - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
63459-541-28
Package Description:
28 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (63459-541-04)
Product Code:
63459-541
Proprietary Name:
Fentora
Non-Proprietary Name:
Fentanyl
Substance Name:
Fentanyl Citrate
Usage Information:
This medication is used to help relieve sudden (breakthrough) cancer pain in people who are regularly taking moderate to large amounts of opioid pain medication. Fentanyl 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. This medication should not be used to relieve mild or short-term pain (such as due to headache/migraine, dental procedures, surgery).
11-Digit NDC Billing Format:
63459054128
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
28 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 668363 - fentaNYL 100 MCG Buccal Tablet
  • RxCUI: 668363 - fentanyl 0.1 MG Buccal Tablet
  • RxCUI: 668363 - fentanyl (as fentanyl citrate) 100 MCG Buccal Tablet
  • RxCUI: 668364 - fentaNYL 200 MCG Buccal Tablet
  • RxCUI: 668364 - fentanyl 0.2 MG Buccal Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Cephalon, Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Buccal - Administration directed toward the cheek, generally from within the mouth.
  • Sublingual - Administration beneath the tongue.
    • Active Ingredient(s):
  • FENTANYL CITRATE 100 ug/1
    • Pharmacologic Class(es):
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA021947
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-02-2006
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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 63459-541-28?

    The NDC Packaged Code 63459-541-28 is assigned to a package of 28 blister pack in 1 carton / 1 tablet in 1 blister pack (63459-541-04) of Fentora, a human prescription drug labeled by Cephalon, Llc. The product's dosage form is tablet and is administered via buccal; sublingual form.This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package.

    Is NDC 63459-541 included in the NDC Directory?

    Yes, Fentora with product code 63459-541 is active and included in the NDC Directory. The product was first marketed by Cephalon, Llc on October 02, 2006 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63459-541-28?

    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 28.

    What is the 11-digit format for NDC 63459-541-28?

    The 11-digit format is 63459054128. 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
    5-3-263459-541-285-4-263459-0541-28