Sublocade Solution
NDC Package 12496-0100-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Sublocade (buprenorphine) solution is buprenorphine is used to treat opioid use disorder. This formulation utilizes a solution delivery system. Marketed by Indivior Inc., this product is identified by NDC 12496-0100 and is authorized under FDA application NDA209819.

Identification & Billing

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
11-Digit Billing Format
12496010001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sublocade
Non-Proprietary Name
Buprenorphine
Substance Name
Buprenorphine
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
BUPRENORPHINE 100 mg/1
Pharmacologic Class
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).
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Indivior Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA209819
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-26-2018
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

Q9991
Source: ASP
Buprenorph xr 100 mg or less
HCPCS Dosage Less than or equal to 100 MG
Units / Pkg 1

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 12496-0100-1 identifies a specific commercial 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.. This solution is formulated for subcutaneous use and contains buprenorphine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Indivior Inc. on February 26, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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).

How is this Indivior Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12496010001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
12496-0100-1
11-Digit CMS (5-4-2)
12496-0100-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.