Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate Tablet
NDC Package 70518-3844-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Remedyrepack Inc., this product is identified by NDC 70518-3844 and is authorized under FDA application ANDA203326.

Identification & Billing

NDC Package Code
70518-3844-0
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
70518-3844
11-Digit Billing Format
70518384400
RxNorm Crosswalk
  • RxCUI: 351267 - buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet
  • RxCUI: 351267 - buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet
  • RxCUI: 351267 - buprenorphine 8 MG (as buprenorphine HCl) / naloxone 2 MG (as naloxone HCl) Sublingual Tablet

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 to include counseling and psychosocial support.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203326
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-29-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70518-3844-0 identifies a specific commercial package of 30 tablet in 1 blister pack of Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate, a human prescription drug labeled by Remedyrepack Inc.. 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 Remedyrepack Inc. on August 29, 2023. The current certification is valid through December 31, 2027.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518384400. 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)
70518-3844-0
11-Digit CMS (5-4-2)
70518-3844-00

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