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  5. NDC Package Code: 51862-635-28 Fentanyl Buccal

NDC Package 51862-635-28 Fentanyl Buccal

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 discontinued by the firm.

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:
51862-635-28
Package Description:
28 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (51862-635-01)
Product Code:
51862-635
Proprietary Name:
Fentanyl Buccal
Usage Information:
Fentanyl buccal tablet is indicated for the management of breakthrough pain in cancer patients 18 years of age and older 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 per day, at least 25 mcg per hour of transdermal fentanyl, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids while taking fentanyl buccal tablet.
11-Digit NDC Billing Format:
51862063528
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:
Labeler Name:
Mayne Pharma
Sample Package:
No
FDA Application Number:
NDA021947
Marketing Category:
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date:
06-14-2019
End Marketing Date:
01-31-2025
Listing Expiration Date:
01-31-2025
Exclude Flag:
D
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 51862-635-28?

The NDC Packaged Code 51862-635-28 is assigned to a package of 28 blister pack in 1 carton / 1 tablet in 1 blister pack (51862-635-01) of Fentanyl Buccal, labeled by Mayne Pharma. 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 28 billable units per package.

Is NDC 51862-635 included in the NDC Directory?

No, Fentanyl Buccal with product code 51862-635 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Mayne Pharma on June 14, 2019 and its listing in the NDC Directory is set to expire on January 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 51862-635-28?

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 51862-635-28?

The 11-digit format is 51862063528. 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
5-3-251862-635-285-4-251862-0635-28