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  5. NDC Package Code: 59385-022-60 Belbuca

NDC Package 59385-022-60 Belbuca

Buprenorphine Hydrochloride Film, Soluble Buccal - 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:
59385-022-60
Package Description:
60 POUCH in 1 CARTON / 1 FILM, SOLUBLE in 1 POUCH (59385-022-01)
Product Code:
59385-022
Proprietary Name:
Belbuca
Non-Proprietary Name:
Buprenorphine Hydrochloride
Substance Name:
Buprenorphine Hydrochloride
Usage Information:
Buprenorphine is used to help relieve severe ongoing pain. Buprenorphine 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. Do not use this medication to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
11-Digit NDC Billing Format:
59385002260
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
60 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1716057 - buprenorphine HCl 150 MCG Buccal Film
  • RxCUI: 1716057 - buprenorphine 0.15 MG Buccal Film
  • RxCUI: 1716063 - Belbuca 150 MCG Buccal Film
  • RxCUI: 1716063 - buprenorphine 0.15 MG Buccal Film [Belbuca]
  • RxCUI: 1716063 - Belbuca 0.15 MG (as buprenorphine HCl) Buccal Film
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Biodelivery Sciences International Inc
    Dosage Form:
    Film, Soluble - A thin layer or coating which is susceptible to being dissolved when in contact with a liquid.
    Administration Route(s):
  • Buccal - Administration directed toward the cheek, generally from within the mouth.
    • Active Ingredient(s):
  • BUPRENORPHINE HYDROCHLORIDE 150 ug/1
    • Pharmacologic Class(es):
  • Partial Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Partial Opioid Agonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule III (CIII) Substances
    Sample Package:
    No
    FDA Application Number:
    NDA207932
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    10-01-2017
    Listing Expiration Date:
    12-31-2025
    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 59385-022-60?

    The NDC Packaged Code 59385-022-60 is assigned to a package of 60 pouch in 1 carton / 1 film, soluble in 1 pouch (59385-022-01) of Belbuca, a human prescription drug labeled by Biodelivery Sciences International Inc. The product's dosage form is film, soluble and is administered via buccal form.

    Is NDC 59385-022 included in the NDC Directory?

    Yes, Belbuca with product code 59385-022 is active and included in the NDC Directory. The product was first marketed by Biodelivery Sciences International Inc on October 01, 2017 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 59385-022-60?

    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 60.

    What is the 11-digit format for NDC 59385-022-60?

    The 11-digit format is 59385002260. 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
    5-3-259385-022-605-4-259385-0022-60