Buprenorphine And Naloxone Film
NDC Package 0378-8765-93

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

Package Information

Buprenorphine And Naloxone films is buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. This formulation utilizes a film delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-8765 and is authorized under FDA application ANDA211785.

Identification & Billing

NDC Package Code
0378-8765-93
Package Description
30 POUCH in 1 CARTON / 1 FILM in 1 POUCH (0378-8765-16)
Product Code
0378-8765
11-Digit Billing Format
00378876593
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
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: 1010604 - buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Film
  • RxCUI: 1010604 - buprenorphine 8 MG / naloxone 2 MG Sublingual Film

Clinical Specifications

Proprietary Name
Buprenorphine And Naloxone
Non-Proprietary Name
Buprenorphine And Naloxone
Substance Name
Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate
Dosage Form
Film - A thin layer or coating.
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
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.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211785
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-17-2020
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 0378-8765-93 identifies a specific commercial package of 30 pouch in 1 carton / 1 film in 1 pouch (0378-8765-16) of Buprenorphine And Naloxone, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This film is formulated for buccal; sublingual use and contains buprenorphine hydrochloride; naloxone hydrochloride dihydrate 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 Mylan Pharmaceuticals Inc. on April 17, 2020. The current certification is valid through December 31, 2027.

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378876593. 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 (4-4-2)
0378-8765-93
11-Digit CMS (5-4-2)
00378-8765-93

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