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  5. NDC Package Code: 12496-0100-1 Sublocade

NDC Package 12496-0100-1 Sublocade

Buprenorphine Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    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:
12496-0100-1
Package Description:
1 POUCH in 1 CARTON / 1 SYRINGE in 1 POUCH (12496-0100-2) / 1 SOLUTION in 1 SYRINGE (12496-0100-5)
Product Code:
12496-0100
Proprietary Name:
Sublocade
Non-Proprietary Name:
Buprenorphine
Substance Name:
Buprenorphine
Usage Information:
Buprenorphine is used to treat opioid use disorder. This long-acting form of buprenorphine should be used only after treatment with a transmucosal form of buprenorphine (one that is used under the tongue or inside the cheek) has been taken for at least 7 days. Buprenorphine belongs to a class of drugs known as mixed opioid agonist-antagonists. It helps prevent withdrawal symptoms caused by stopping other opioids. It is used as part of a complete treatment program for opioid use disorder (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).
11-Digit NDC Billing Format:
12496010001
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1996184 - buprenorphine 100 MG in 0.5 mL Prefilled Syringe
  • RxCUI: 1996184 - 0.5 ML buprenorphine 200 MG/ML Prefilled Syringe
  • RxCUI: 1996184 - buprenorphine 100 MG per 0.5 ML Prefilled Syringe
  • RxCUI: 1996189 - SUBLOCADE 100 MG in 0.5 mL Prefilled Syringe
  • RxCUI: 1996189 - 0.5 ML buprenorphine 200 MG/ML Prefilled Syringe [Sublocade]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Indivior Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Active Ingredient(s):
  • BUPRENORPHINE 100 mg/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:
    NDA209819
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    02-26-2018
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 12496-0100-1 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    12496010001Q9991Buprenorph xr 100 mg or lessLESS THAN OR EQUAL TO 100 MG0.5111

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 12496-0100-1?

    The NDC Packaged Code 12496-0100-1 is assigned to a package of 1 pouch in 1 carton / 1 syringe in 1 pouch (12496-0100-2) / 1 solution in 1 syringe (12496-0100-5) of Sublocade, a human prescription drug labeled by Indivior Inc.. The product's dosage form is solution and is administered via subcutaneous form.

    Is NDC 12496-0100 included in the NDC Directory?

    Yes, Sublocade with product code 12496-0100 is active and included in the NDC Directory. The product was first marketed by Indivior Inc. on February 26, 2018 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 12496-0100-1?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 12496-0100-1?

    The 11-digit format is 12496010001. 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
    5-4-112496-0100-15-4-212496-0100-01