Buprenorphine And Naloxone
NDC Package 60846-970-03

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Buprenorphine And Naloxone is a . Marketed by Gemini Laboratories, Llc, this product is identified by NDC 60846-970 and is authorized under FDA application ANDA203136.

Identification & Billing

NDC Package Code
60846-970-03
Package Description
30 TABLET in 1 BOTTLE
Product Code
60846-970
11-Digit Billing Format
60846097003

Clinical Specifications

Proprietary Name
Buprenorphine And Naloxone
Dosage Form
-

Regulatory & Marketing

Labeler Name
Gemini Laboratories, Llc
FDA Application #
ANDA203136
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-22-2013
End Marketing Date
03-22-2019
Listing Expiration
03-22-2019
Exclude Flag
D
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 60846-970-03 identifies a specific commercial package of 30 tablet in 1 bottle of Buprenorphine And Naloxone, labeled by Gemini Laboratories, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Gemini Laboratories, Llc on February 22, 2013. The current certification is valid through March 22, 2019.

How is this Gemini Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60846097003. 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 (5-3-2)
60846-970-03
11-Digit CMS (5-4-2)
60846-0970-03

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