Fentanyl Buccal
NDC Package 51862-635-28

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 discontinued by the firm.

Fentanyl Buccal is a . Marketed by Mayne Pharma, this product is identified by NDC 51862-635 and is authorized under FDA application NDA021947.

Identification & Billing

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
11-Digit Billing Format
51862063528
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA

Clinical Specifications

Proprietary Name
Fentanyl Buccal
Dosage Form
-

Regulatory & Marketing

Labeler Name
Mayne Pharma
FDA Application #
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
01-31-2025
Exclude Flag
D
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 51862-635-28 identifies a specific commercial package of 28 blister pack in 1 carton / 1 tablet in 1 blister pack (51862-635-01) of Fentanyl Buccal, labeled by Mayne Pharma. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 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 Mayne Pharma on June 14, 2019. The current certification is valid through January 31, 2025.

How is this Mayne Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51862063528. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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)
51862-635-28
11-Digit CMS (5-4-2)
51862-0635-28

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