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  5. NDC Package Code: 47781-357-03 Buprenorphine And Naloxone Sublingual Film

NDC Package 47781-357-03 Buprenorphine And Naloxone Sublingual Film

Film 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:
47781-357-03
Package Description:
30 POUCH in 1 CARTON / 1 FILM in 1 POUCH (47781-357-11)
Product Code:
47781-357
Proprietary Name:
Buprenorphine And Naloxone Sublingual Film
Non-Proprietary Name:
Buprenorphine And Naloxone
Substance Name:
Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate
Usage Information:
Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.
11-Digit NDC Billing Format:
47781035703
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1010600 - buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Film
  • RxCUI: 1010600 - buprenorphine 2 MG / naloxone 0.5 MG Sublingual Film
  • RxCUI: 1010600 - buprenorphine 2 MG / naloxone 0.5 MG Buccal Film
  • RxCUI: 1010604 - buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Film
  • RxCUI: 1010604 - buprenorphine 8 MG / naloxone 2 MG Sublingual Film
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alvogen Inc.
    Dosage Form:
    Film - A thin layer or coating.
    Administration Route(s):
  • Buccal - Administration directed toward the cheek, generally from within the mouth.
  • Sublingual - Administration beneath the tongue.
    • Active Ingredient(s):
  • BUPRENORPHINE HYDROCHLORIDE 8 mg/1
  • NALOXONE HYDROCHLORIDE DIHYDRATE 2 mg/1
    • Pharmacologic Class(es):
  • Opioid Antagonist - [EPC] (Established Pharmacologic Class)
  • Opioid Antagonists - [MoA] (Mechanism of Action)
  • 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:
    ANDA205954
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-11-2019
    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 47781-357-03?

    The NDC Packaged Code 47781-357-03 is assigned to a package of 30 pouch in 1 carton / 1 film in 1 pouch (47781-357-11) of Buprenorphine And Naloxone Sublingual Film, a human prescription drug labeled by Alvogen Inc.. The product's dosage form is film and is administered via buccal; sublingual form.

    Is NDC 47781-357 included in the NDC Directory?

    Yes, Buprenorphine And Naloxone Sublingual Film with product code 47781-357 is active and included in the NDC Directory. The product was first marketed by Alvogen Inc. on February 11, 2019 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 47781-357-03?

    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 30.

    What is the 11-digit format for NDC 47781-357-03?

    The 11-digit format is 47781035703. 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
    5-3-247781-357-035-4-247781-0357-03