Buprenorphine Hcl
NDC Package 76519-1170-2

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Buprenorphine Hcl is buprenorphine is used to treat dependence/addiction to opioids. Marketed by H.j. Harkins Company, Inc., this product is identified by NDC 76519-1170 and is authorized under FDA application ANDA078633.

Identification & Billing

NDC Package Code
76519-1170-2
Package Description
56 TABLET in 1 BOTTLE
Product Code
76519-1170
11-Digit Billing Format
76519117002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Buprenorphine Hcl SL
Dosage Form
-
Usage Information
Buprenorphine is used to treat dependence/addiction to opioids. Buprenorphine belongs to a class of drugs called 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 drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

Regulatory & Marketing

Labeler Name
H.j. Harkins Company, Inc.
FDA Application #
ANDA078633
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-16-2018
Listing Expiration
12-31-2019
Exclude Flag
I
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 (76519-1170). Click a package code to view its specific billing and regulatory data.

76519-1170-0
14 TABLET in 1 BOTTLE
76519-1170-1
28 TABLET in 1 BOTTLE
76519-1170-3
70 TABLET in 1 BOTTLE
76519-1170-4
84 TABLET in 1 BOTTLE
76519-1170-5
42 TABLET in 1 BOTTLE

* 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 76519-1170-2 identifies a specific commercial package of 56 tablet in 1 bottle of Buprenorphine Hcl SL, labeled by H.j. Harkins Company, Inc.. 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 H.j. Harkins Company, Inc. on March 16, 2018. The current certification is valid through December 31, 2019.

What are the primary indications for this medication?

Buprenorphine is used to treat dependence/addiction to opioids. Buprenorphine belongs to a class of drugs called 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 drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

How is this H.j. Harkins Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76519117002. 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)
76519-1170-2
11-Digit CMS (5-4-2)
76519-1170-02

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