Suboxone Film, Soluble
NDC Package 12496-1202-3

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

Package Information

Suboxone (buprenorphine hydrochloride, naloxone hydrochloride) films is this medication contains 2 medicines: buprenorphine and naloxone. This formulation utilizes a film, soluble delivery system. Marketed by Indivior Inc., this product is identified by NDC 12496-1202 and is authorized under FDA application NDA022410.

Identification & Billing

NDC Package Code
12496-1202-3
Package Description
30 POUCH in 1 CARTON / 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1)
Product Code
12496-1202
11-Digit Billing Format
12496120203
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Suboxone
Non-Proprietary Name
Buprenorphine Hydrochloride, Naloxone Hydrochloride
Substance Name
Buprenorphine Hydrochloride; Naloxone Hydrochloride
Dosage Form
Film, Soluble - A thin layer or coating which is susceptible to being dissolved when in contact with a liquid.
Administration Route
  • Buccal - Administration directed toward the cheek, generally from within the mouth.
  • Sublingual - Administration beneath the tongue.
Active Ingredient(s)
Pharmacologic Class
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).
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Indivior Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022410
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-13-2010
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 12496-1202-3 identifies a specific commercial package of 30 pouch in 1 carton / 1 film, soluble in 1 pouch (12496-1202-1) of Suboxone, a human prescription drug labeled by Indivior Inc.. This film, soluble is formulated for buccal; sublingual use and contains buprenorphine hydrochloride; naloxone hydrochloride 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 September 13, 2010. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12496120203. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
12496-1202-3
11-Digit CMS (5-4-2)
12496-1202-03

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