Buprenorphine Hcl Tablet
NDC Package 70518-2014-1

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 Hcl tablets is buprenorphine is used to treat dependence/addiction to opioids. This formulation utilizes a tablet delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-2014 and is authorized under FDA application ANDA078633.

Identification & Billing

NDC Package Code
70518-2014-1
Package Description
60 TABLET in 1 BOTTLE, PLASTIC
Product Code
70518-2014
11-Digit Billing Format
70518201401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Buprenorphine Hcl
Non-Proprietary Name
Buprenorphine Hcl
Substance Name
Buprenorphine Hydrochloride
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)
BUPRENORPHINE HYDROCHLORIDE 8 mg/1
Pharmacologic Class
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).
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078633
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-12-2019
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 (70518-2014). Click a package code to view its specific billing and regulatory data.

70518-2014-0
30 TABLET in 1 BLISTER PACK

* 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 70518-2014-1 identifies a specific commercial package of 60 tablet in 1 bottle, plastic of Buprenorphine Hcl, a human prescription drug labeled by Remedyrepack Inc.. This tablet is formulated for sublingual use and contains buprenorphine hydrochloride 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 Remedyrepack Inc. on April 12, 2019. The current certification is valid through December 31, 2027.

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 Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518201401. 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)
70518-2014-1
11-Digit CMS (5-4-2)
70518-2014-01

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