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  5. NDC Package Code: 12496-1204-3 Suboxone

NDC Package 12496-1204-3 Suboxone

Buprenorphine Hydrochloride,Naloxone Hydrochloride Film, Soluble 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:
12496-1204-3
Package Description:
30 POUCH in 1 CARTON / 1 FILM, SOLUBLE in 1 POUCH (12496-1204-1)
Product Code:
12496-1204
Proprietary Name:
Suboxone
Non-Proprietary Name:
Buprenorphine Hydrochloride, Naloxone Hydrochloride
Substance Name:
Buprenorphine Hydrochloride; Naloxone Hydrochloride
Usage Information:
This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat opioid dependence/addiction. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opioids. Naloxone is an opioid antagonist that blocks the effect of opioids and can cause severe opioid withdrawal when injected. Withdrawal is less likely when naloxone is taken by mouth, dissolved under the tongue, or dissolved on the inside of the cheek. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).
11-Digit NDC Billing Format:
12496120403
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: 1010603 - Suboxone 2 MG / 0.5 MG Sublingual Film
  • RxCUI: 1010603 - buprenorphine 2 MG / naloxone 0.5 MG Sublingual Film [Suboxone]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Indivior 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.
  • Sublingual - Administration beneath the tongue.
    • Active Ingredient(s):
  • BUPRENORPHINE HYDROCHLORIDE 4 mg/1
  • NALOXONE HYDROCHLORIDE 1 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:
    NDA022410
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-24-2012
    Listing Expiration Date:
    12-31-2024
    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 12496-1204-3?

    The NDC Packaged Code 12496-1204-3 is assigned to a package of 30 pouch in 1 carton / 1 film, soluble in 1 pouch (12496-1204-1) of Suboxone, a human prescription drug labeled by Indivior Inc.. The product's dosage form is film, soluble and is administered via buccal; sublingual form.

    Is NDC 12496-1204 included in the NDC Directory?

    Yes, Suboxone with product code 12496-1204 is active and included in the NDC Directory. The product was first marketed by Indivior Inc. on August 24, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 12496-1204-3?

    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 12496-1204-3?

    The 11-digit format is 12496120403. 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
    5-4-112496-1204-35-4-212496-1204-03