Buprenorphine Hydrochloride Sublingual
NDC Package 67046-997-30

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 inactivated by the FDA.

Buprenorphine Hydrochloride Sublingual is tablets are indicated for the treatment of opioid dependence and are preferred for induction. Marketed by Contract Pharmacy Services-pa, this product is identified by NDC 67046-997 and is authorized under FDA application ANDA201066.

Identification & Billing

NDC Package Code
67046-997-30
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
67046-997
11-Digit Billing Format
67046099730
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Buprenorphine Hydrochloride Sublingual
Dosage Form
-
Usage Information
Buprenorphine hydrochloride sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine hydrochloride sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

Regulatory & Marketing

Labeler Name
Contract Pharmacy Services-pa
FDA Application #
ANDA201066
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-06-2015
Listing Expiration
12-31-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67046-997-30 identifies a specific commercial package of 30 tablet in 1 blister pack of Buprenorphine Hydrochloride Sublingual, labeled by Contract Pharmacy Services-pa. 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 Contract Pharmacy Services-pa on March 06, 2015. The current certification is valid through December 31, 2021.

How is this Contract Pharmacy Services-pa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046099730. 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)
67046-997-30
11-Digit CMS (5-4-2)
67046-0997-30

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