NDC Package 51862-638-28 Fentanyl Buccal

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

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:
51862-638-28
Package Description:
28 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (51862-638-01)
Product Code:
Proprietary Name:
Fentanyl Buccal
Non-Proprietary Name:
Fentanyl Citrate
Substance Name:
Fentanyl Citrate
Usage Information:
This medication is used to help relieve sudden (breakthrough) pain in people who are already taking opioid medication around-the-clock for cancer pain. 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:
51862063828
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:
    Mayne Pharma
    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):
    DEA Schedule:
    Schedule II (CII) Substances
    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:
    01-31-2026
    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 51862-638-28?

    The NDC Packaged Code 51862-638-28 is assigned to a package of 28 blister pack in 1 carton / 1 tablet in 1 blister pack (51862-638-01) of Fentanyl Buccal, a human prescription drug labeled by Mayne Pharma. 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 51862-638 included in the NDC Directory?

    Yes, Fentanyl Buccal with product code 51862-638 is active and included in the NDC Directory. The product was first marketed by Mayne Pharma on June 14, 2019.

    What is the NDC billing unit for package 51862-638-28?

    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 51862-638-28?

    The 11-digit format is 51862063828. 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
    5-3-251862-638-285-4-251862-0638-28