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  5. NDC Package Code: 67296-1877-3 Buprenorphine And Naloxone

NDC Package 67296-1877-3 Buprenorphine And Naloxone

Film Buccal; Sublingual - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
67296-1877-3
Package Description:
30 FILM in 1 BOTTLE
Product Code:
67296-1877
Proprietary Name:
Buprenorphine And Naloxone
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:
67296187703
NDC to RxNorm Crosswalk:
  • RxCUI: 1010604 - buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Film
  • RxCUI: 1010604 - buprenorphine 8 MG / naloxone 2 MG Sublingual Film
  • RxCUI: 1010604 - buprenorphine 8 MG / naloxone 2 MG Buccal Film
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Redpharm Drug
    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:
    ANDA207607
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-20-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    67296-1877-99 FILM in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 67296-1877-3?

    The NDC Packaged Code 67296-1877-3 is assigned to a package of 30 film in 1 bottle of Buprenorphine And Naloxone, a human prescription drug labeled by Redpharm Drug. The product's dosage form is film and is administered via buccal; sublingual form.

    Is NDC 67296-1877 included in the NDC Directory?

    Yes, Buprenorphine And Naloxone with product code 67296-1877 is active and included in the NDC Directory. The product was first marketed by Redpharm Drug on February 20, 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 11-digit format for NDC 67296-1877-3?

    The 11-digit format is 67296187703. 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 5-4-1 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
    5-4-167296-1877-35-4-267296-1877-03