Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate Tablet
NDC Package 67296-2191-1

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

Package Information

Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate tablets is buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. This formulation utilizes a tablet delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2191 and is authorized under FDA application ANDA209069.

Identification & Billing

NDC Package Code
67296-2191-1
Package Description
12 TABLET in 1 BOTTLE, PLASTIC
Product Code
67296-2191
11-Digit Billing Format
67296219101

Clinical Specifications

Proprietary Name
Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Non-Proprietary Name
Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Substance Name
Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets 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
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
ANDA209069
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67296-2191). Click a package code to view its specific billing and regulatory data.

67296-2191-6
6 TABLET in 1 BOTTLE, PLASTIC

* 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 67296-2191-1 identifies a specific commercial package of 12 tablet in 1 bottle, plastic of Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate, a human prescription drug labeled by Redpharm Drug. This tablet is formulated for 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 Redpharm Drug on September 01, 2020. The current certification is valid through December 31, 2027.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296219101. 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)
67296-2191-1
11-Digit CMS (5-4-2)
67296-2191-01

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